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U.S. Department of Health and Human Services

Class 3 Device Recall Ocular Conformer

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  Class 3 Device Recall Ocular Conformer see related information
Date Initiated by Firm March 28, 2008
Date Posted September 20, 2008
Recall Status1 Terminated 3 on October 10, 2008
Recall Number Z-2302-2008
Recall Event ID 48722
510(K)Number K972034  
Product Classification Conformer, ophthalmic - Product Code HQN
Product Ocular Conformer, Sterile, Porex Surgical Inc., 15 Dart Road, Newnan, GA 30265.
The device is intended to be used as a post eye surgery device to prevent closure or adhesion during the healing process.
Code Information Catalog number: 9574, Lot number 001061103C, Catalog number 9548, Lot number 002010204-C, Catalog number 9549, Lot number 003061103C, Catalog number 9779, Lot number 002050804C and Catalog number 9780, Lot number 006101204-C.
Recalling Firm/
Manufacturer		 Porex Surgical, Inc.
15 Dart Rd
Newnan GA 30265-1017
For Additional Information Contact Jerry Davis
770-515-7735
Manufacturer Reason
for Recall		 The Ocular Conformers were distributed with an expired expiration date.
FDA Determined
Cause 2		 Employee error
Action Consignees were contacted by phone on 03/28/2008. A follow up letter was sent on/about 03/31/2008. Consignees were instructed to examine their inventory and to quarantine Ocular Conformers containing the affected lots. These units should be returned to Porex Surgical using a Return Authorization Number provided. If the units were distributed, consignees were advised to contact their customers and inform them of the recall. They were informed the recall was being conducted to the physician level. Contact Porex Surgical at 1-770-515-7735 for assistance.
Quantity in Commerce 9 units
Distribution PA, Canada and Germany
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.
510(K) Database 510(K)s with Product Code = HQN and Original Applicant = POREX SURGICAL, INC.
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