| Class 2 Device Recall Healon | |
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
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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 |
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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.
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PMA Database | PMAs with Product Code = LZP
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