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U.S. Department of Health and Human Services

Class 2 Device Recall Healon

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  Class 2 Device Recall Healon see related information
Date Initiated by Firm April 01, 2017
Create Date May 10, 2017
Recall Status1 Terminated 3 on November 27, 2017
Recall Number Z-2062-2017
Recall Event ID 77023
PMA Number P810031 
Product Classification Aid, surgical, viscoelastic - Product Code LZP
Product Healon, Part No. 10290953, 10295210, 10200011, 10200012, 10201012, 10203012, 10213012, 10223012, 10290701, 10294751, 10295701
Code Information UB32602, UB32593, UB32514, UB32521, UB32579, UB32573, UB32599, UB32614, UB32616, UB32533
Recalling Firm/
Manufacturer		 Abbott Medical Optics Inc. (AMO)
1700 E Saint Andrew Pl
Santa Ana CA 92705-4933
For Additional Information Contact
714-247-8200
Manufacturer 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.
FDA Determined
Cause 2		 Process design
Action 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.
Quantity in Commerce 293,867 units total
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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LZP and Original Applicant = Johnson & Johnson Surgical Vision, Inc.
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