Recall Z-2220-2010 ยท KYG Device, Irrigation, Ocular Surgery
Insight Instruments, Inc.
CORNEA COAT Hydroxypropylmethylcellulose 1.5ml Syringe. STERILE, Rx ONLY. Manufactured by: Insight Instruments, Inc., 2580 SE Willoughby Blvd. Stuart, FL 34994 USA. REF 60010.000, QTY 14 - This package contains 14 individual packs, each containing 1 sterile, single use ocular irrigation device. For external use only! Used as an ocular irrigation device.
| 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 | 16,128 |
| 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.