FDA Recall Terminated

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

Recall: Z-1092-2007 · Initiated May 25, 2007

Recall

Recall Number: Z-1092-2007
Event Number: 38019
Firm: Advanced Medical Optics, Inc.
FEI Number: 3003843509
Product Code: LPN
Status: Terminated
Root Cause: Labeling design
Initiated: May 25, 2007
Posted: July 19, 2007
Terminated: January 10, 2012
Address: 1700 E Saint Andrew Pl, Santa Ana, CA, 92705-4933

Description

Reason

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.

Action

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.

Distribution

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).

Quantity

27,807,198 units in US (57,252,581 Worldwide)