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Class 2 Device Recall BIOM PACK |
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| Date Initiated by Firm |
May 12, 2010 |
| Date Posted |
August 13, 2010 |
| Recall Status1 |
Terminated 3 on February 16, 2012 |
| Recall Number |
Z-2221-2010 |
| Recall Event ID |
56246 |
| Product Classification |
Ocular Surgery Irrigation Device - Product Code KYG
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| Product |
BIOM PACK, Contents Individually Sterile. QTY 5 EA. Each Pack Contains: 1 EA. Microscope Drape (REF40100), 1 EA. Cornea Coat (REF 60010), 1 EA. SuperView BIOM Lens Set (REF 40411).
Manufactured by: Insight Instruments, Inc., 2580 SE Willoughby Blvd. Stuart, FL 34994 USA.
Item # 40201:
Item Lot # Cornea Coat Lot # Expiration Date
M423801008 M419300908 2010-07
M427731108 M419300908 2010-07
M428631008 M419300908 2010-07
M434211208 M422951008 2010-08
M439670109 M422951008 2010-08
M443700109 M435381208 2010-09
M44887 M442120109 2010-10
Item # 40202:
Item Lot # Cornea Coat Lot # Expiration Date
M427641008 M419300908 2010-07
M45414 M435381208 2010-09
Item # 40203:
M416600908 M415950808 2010-06
M422941008 M416620908 2010-07
M427651108 M422951008 2010-08
M442710109 M435381208 2010-09
M44870 M442120109 2010-10
Item # 40204:
Item Lot # Cornea Coat Lot # Expiration Date
M421580908 M416620908 2010-07
M435201208 M422951008 2010-08
M45645 M435381208 2010-09
Item # 40205:
Item Lot # Cornea Coat Lot # Expiration Date
M410510708 M409570708 2010-05
M412790708 M409570708 2010-05
M419280908 M415950808 2010-06
M420850908 M415950808 2010-06
M421100908 M416620908 2010-07
M421120908 M416620908 2010-07
M424361008 M419300908 2010-07
M425821008 M421680908 2010-07
M426731008 M421680908 2010-07
M428601008 M419300908 2010-07
M429531108 M421680908 2010-07
M430851108 M421680908 2010-07
M431051108 M422951008 2010-08
M433111108 M422951008 2010-08
M435531208 M430041108 2010-09
M440700109 M430041108 2010-09
M441790109 M435381208 2010-09
M442560109 M430041108 2010-09
M443450109 M422951008 2010-08
M443930109 M442120109 2010-10
M44605 M442120109 2010-10
M44896 M44499 2010-11
M45099 M44499 2010-11
M45243 M435381208 2010-09
M45248 M44897 2010-12
M45866 M44897 2010-12
M45870 M435381208 2010-09
Item # 10206:
Item Lot # Cornea Coat Lot # Expiration Date
M418460908 M416620908 2010-07
M434741208 M422951008 2010-08
M45646 M435381208 2010-09
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| Code Information |
Cornea Coat Lot Codes: M408080708, M409570708, M414420808, M415940808, M415950808, M416620908, M419300908, M421610908, M421680908, M422951008, M427661108, M430041108, M435381208, M442120109, M44499, M44744, M44897. |
Recalling Firm/
Manufacturer |
Insight Instruments, Inc.
2580 Se Willoughby Blvd
Stuart FL 34994-4701
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| For Additional Information Contact |
727-219-9393
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Manufacturer Reason
for Recall |
Insight Instruments, Inc., Stuart, FL is recalling CORNEA COAT 2.5% Hydroxypropylmethylcellulose solution in 1.5 ml Syringe due to a potential weakness of the peel pouch seals. Products affected are Item Numbers 600100.000 sold individually and 40201.000 thru 10206.000 sold as components of BIOM Pack.
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FDA Determined
Cause 2 |
Packaging |
| Action |
All consignees were notified of the recall by letter sent via first class mail. Letter contained a Return Response Form. |
| Quantity in Commerce |
50,725 |
| Distribution |
Worldwide Distribution -- USA, including Puerto Rico, and Frankfurt, Germany. |
| 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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