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U.S. Department of Health and Human Services

Class 3 Device Recall OptiLITE IX Laser Surgery Accessories

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 Class 3 Device Recall OptiLITE IX Laser Surgery Accessoriessee related information
Date Initiated by FirmOctober 29, 2017
Date PostedOctober 18, 2019
Recall Status1 Terminated 3 on April 28, 2021
Recall NumberZ-0162-2020
Recall Event ID 83902
510(K)NumberK992866 
Product Classification Powered Laser Surgical Instrument - Product Code GEX
ProductOptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium fiber assembly with flat tip, Lot Number 21144, Sterilized by Sterrad Run 4149, This device is for single-use only, sterile, UDI: 00855430006036
Code Information Lot # 21144, Use by 08/10/2021
FEI Number 2938889
Recalling Firm/
Manufacturer		 Xintec Corp
1660 S Loop Rd
Alameda CA 94502-7091
For Additional Information ContactJennifer Mok
510-832-2130 Ext. 1207
Manufacturer Reason
for Recall		It has been determined that a lot of fiber lasers were programmed incorrectly. As a result, the fibers from this lot will produce an error and will not allow the user to use the laser when it is plugged in.
FDA Determined
Cause 2		Software Manufacturing/Software Deployment
ActionOn October 29, 2017, the firm contacted consignees via phone. During the phone the following information was provided: 1. Convergent has become aware of an issue affecting one lot of the fibers that have been purchased recently. The affected product is the CGH1080F fibers with lot number 21144. It has been determined that the fibers in that batch were programmed incorrectly. As a result, the fibers from this lot will produce an error and will not allow the user to use the laser with it is plugged in. There have been no reports of adverse reactions related to this issue. Please return the products to Convergent. In return, we will send replacement fibers to you.
Quantity in Commerce45 lasers
DistributionPA and VA
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GEX
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