Healon, Part No. 10290953, 10295210, 10200011, 10200012, 10201012, 10203012, 10213012, 10223012, 10290701, 10294751, 10295701
- Company
- Abbott Medical Optics Inc (Amo)
- Recall Initiated
- April 1, 2017
- Terminated
- November 27, 2017
- Recall Number
- Z-2062-2017
- Quantity
- 293,867 units total
- Firm Location
- Santa Ana, CA
Reason for Recall
Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process.
Distribution
US and worldwide: Austria Belgium Croatia Czech Republic Denmark Finland France Germany Great Britain Iceland Ireland Israel Italy Latvia Lebanon Lithuania Netherlands Norway Portugal Spain Sweden Switzerland Tunisia Turkey Russian Fed Guadeloupe Sri Lanka Australia China Hong Kong Indonesia Malaysia Singapore South Korea Taiwan Thailand Japan Chile Colombia Costa Rica Ecuador
Lot / Code Info
UB32602, UB32593, UB32514, UB32521, UB32579, UB32573, UB32599, UB32614, UB32616, UB32533
Root Cause
Process design
Action Taken
A recall letter was sent to customers on 4/1/17 to inform them that AMO has voluntarily initiated this Action because a remote possibility exists that certain Healon OVD solutions in the affected lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process. Use of OVD solutions with glass particles could potentially lead to intraocular injury. Customers are instructed to complete the Customer Reply Form and fax it to AMO Quality Assurance at 714-247-4510 or email to RegCompliOne@abbott.com within 3 business days of receipt of the letter. Customers with product complaints or adverse events are instructed to inform AMO by calling 877-266-4543. Customers that do report a complaint are instructed to provide the Healon OVD lot number and, if a patient was involved, the date of surgery, a description of the event and patient outcome.