Events

Retiro De Equipo (Recall) de Device Recall COMPLETE MOISTUREPLUS MULTIPURPOSE SOLUTION

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Advanced Medical Optics, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    38019
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1092-2007
  • Fecha de inicio del evento
    2007-05-25
  • Fecha de publicación del evento
    2007-07-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-01-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52779
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    contact lens solution - Product Code LPN
  • Causa
    In response to information received 05/25/2007 from the u.S. centers for disease control and prevention (cdc) regarding eye infections from acanthamoeba, a naturally occurring water-borne organism which can contribute to serious corneal infections. cdc estimates a risk of at least seven times greater for those who use complete moistureplus solution versus those who did not.
  • Acción
    On Friday, May 25, 2007 at 11:16 ET, AMO issued a press release to the market related to the voluntary recall of AMO's COMPLETE MoisturePLUS TM Multi-Purpose Solution from the market. Similar press releases, specific to the geographic regions, were issued in the other markets beginning on Saturday, May 26, 2007. A copy of the United States press release is present on the AMO website (www.amo-inc.com) and was forwarded to the FDA for posting on the FDA web site. In addition, the FDA also completed a press release related to the AMO recall and it is available on the FDA web site. Regulatory agency notifications in all markets affected outside the United States were initiated beginning on Monday, May 28. Beginning on Thursday, May 31, AMO (via Stericycle) distributed RetaiI Customer notification packages via overnight UPS delivery to the 485 customer accounts in the United States.

Device

Device Recall COMPLETE MOISTUREPLUS MULTIPURPOSE SOLUTION
  • Modelo / Serial
    All Lots (773 lots in US, 894 in Europe, 263 in Asia Pacifiic, 111 in China & 184 in Canada).  Each product is clearly identified with a lot number and expiration date, which is displayed on either the outer top or bottom panel of the unit carton and on two case labels on the case shipper. In addition, each bottle is clearly identified with a lot number and expiration date.  The first digit of the lot number denotes the identification of the AMO manufacturing site, Z = Hangzhou, China, A = Alcobendas, Spain.  The second digit denotes the year of manufacture (A= 2005, B = 2006, C = 2007) per AMO Standard Operating Procedure.  The third through the seventh digits denote the sequential number of production orders produced in either the Hangzhou, China or Alcobendas, Spain facility in that year, starting with 00001. Note that several product lines use this lot numbering system in each facility, so the sequential numbering is not unique to any specific product or formulation.  As an example, ZB01234, the lot number represents the 1,234th production order initiated in the Hangzhou, China facility in 2006.
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide including USA, Canada, Europe, Japan, China and various Asia Pacific countries (to include Hong Kong, Australia, New Zealand, Korea, Vietnam, Singapore, India, Indonesia, Sri Lanka, Taiwan, Malaysia, Pakistan and the Philippines).
  • Descripción del producto
    COMPLETE MOISTUREPLUS MULTIPURPOSE SOLUTION, Formula 9451X; || (A) Fourteen US Product Numbers distributed under the COMPLETE MOISTUREPLUS MULTIPURPOSE SOLUTION brand include: 90104 (MoisturePLUS, 12 oz ), 90105 || (MoisturePLUS, 2 X 12 oz), 90106 (Complete MoisturePLUS Lens Comfort Pack), 90168 (Complete MoisturePLUS 2 oz Starter Kit + Lens Case), 90169TR (Complete MoisturePLUS, 2 X 16 oz, TRAY), 90170 (Complete MoisturePLUS, 4 oz + Lens Case), 93184 (Active Pack, Complete MoisturePLUS 2 oz & B-N-C 5m1 + Lens Case), 93185 (Complete MoisturePLUS, 12 oz, BEAUTIFUL EYES PROMO), 93186 (Complete MoisturePLUS, 2 X 12 oz, BEAUTIFUL EYE PROMO), 93187 (Complete MoisturePLUS, 2 X 16 oz, BEAUTIFUL EYES PROMO), 93220 (Rejuvenate Kit -contains Complete MoisturePLUS 90174), || 93221 (Complete MoisturePLUS, 12 oz + Blink Sample), 93280 (Complete Starter Kit -2 oz Complete MoisturePLUS + Lens Case), 93341 (Complete MoisturePLUS, 4 oz); || (B) The same formula (9451X) was sold in (1)Canada (Product Numbers:90113EC, 90175QW, 90176EC, 90177EC, 90187EC & 90197EC), (2)Europe (Product Numbers:90086DF, 90086FC, 90086SA, 90089AX, 90089FP, 90089GB, 90089NR, 90090EQ, 90090GM, 90090RR, 90090RY, 90091EG, 90091GB, 90091GM, 90091KZ, 90091NR, 90091RH, 9009SA, 90096AX, 90096EJ, 90096EQ, 90096EW, 90096FL, 90096FP, 90096GB, 90096GM, 90096LM, 90096RW, 90096RY, 90096SA, 90109FM, 90110EW, 90110FC, 90110FL, 90110KK, 90110KKD, 90115AX, 90115EW, 90115FP, 90115GB, 90115GM, 90115KH, 90117FP, 90117RH, 90118RR, 90119GM, 90119RH, 90124XQ, 90157KK, 90157KKD, 93099EQ, 93099RW, 93136LM, 93137LM, 93365GB & 93365NR) , (3)China (Product Numbers:90281CH, 90282CH, 90283CH, 93095CH, 93191CH, 93262CH, 93283CH, 93404CH, 93407CH, 93416CH & 93464CH) & (4)Various Asia Pacific countries (to include Hong Kong, Australia, New Zealand, Korea, Vietnam, Singapore, India, Indonesia, Sri Lanka, Taiwan, Malaysia, Pakistan and the Philippines) under Product Numbers:90104, 90190ED, 90192ED, 90193ED, 90194ED, 90195ED, 90228ED, 90281AS, 90281KO, 90282AS, 90282KO, 90283AS, 90283KO, 90283UT, 93126AS, 93126KO, 93126UT, 93233UT, 93262AS, 93375AS, 93376AS, 93377AS, 93378AS, 93378AS, 93379AS & 93447AS
  • Manufacturer
    Advanced Medical Optics, Inc.

Manufacturer

Advanced Medical Optics, Inc.
  • Dirección del fabricante
    Advanced Medical Optics, Inc., 1700 E Saint Andrew Pl, Santa Ana CA 92705-4933
  • Source
    USFDA