Recall Z-2221-2010 ยท KYG Device, Irrigation, Ocular Surgery
Insight Instruments, Inc.
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
| Date | Aug 13, 2010 (initiated May 12, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Packaging |
| Action | All consignees were notified of the recall by letter sent via first class mail. Letter contained a Return Response Form. |
| Quantity | 50,725 |
| Distribution | Worldwide Distribution -- USA, including Puerto Rico, and Frankfurt, Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.