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U.S. Department of Health and Human Services

Class 2 Device Recall LenSx Laser System

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  Class 2 Device Recall LenSx Laser System see related information
Date Initiated by Firm April 14, 2016
Create Date May 17, 2016
Recall Status1 Terminated 3 on October 20, 2017
Recall Number Z-1688-2016
Recall Event ID 73883
510(K)Number K120732  
Product Classification Ophthalmic femtosecond laser - Product Code OOE
Product LenSx Laser System. Indicated for use in patients undergoing cataract surgery and refractive surgery.
Code Information Serial Numbers: 0511-A013 0313-A345 0713-A455 0415-A019 0912-A258 0313-A359 1213-A613 0412-A142 0412-A137 1114-A943 0212-A112 0313-A357 0813-A469 1113-A605 0314-A697 0315-A981 0913-A530 1012-A286 0515-A037 1112-A291 0515-A042 1011-A065 1012-A284 1013-A555 1211-A086 1012-A287 0912-A245 0614-A783 1113-A596 1014-A916 1011-A062 0615-A044 0913-A506 0313-A353 0615-A050 0615-A056 0912-A247 1114-A938 0712-A202 0714-A824 0113-A320 0212-A117 0614-A782 0614-A784 1112-A294 0712-A201 0514-A749 0715-A071 1111-A067 1214-A948 1013-A542 0314-A687 1213-A614 0215-A976 0312-A135 1012-A285 1013-A548 0215-A978 0412-A139 1113-A586 0312-A129 1011-A050 1213-A612 0314-A685 1112-A292 1012-A264 1015-A126 1111-A077 1013-A547 1114-A931 0112-A099 0112-A101 0413-A372 0413-A380 0512-A157 0612-A200 0715-A073 0811-A034 0815-A097 1013-A554 1113-A587 
Recalling Firm/
Alcon Research, Ltd.
6201 South Fwy
Fort Worth TX 76134-2099
For Additional Information Contact Alcon Customer Support
Manufacturer Reason
for Recall
Alcon is conducting a voluntary recall of all LenSx Lasers with Corneal Flap Capability after receiving reports concerning incomplete corneal flap creation, which manifests as an un-dissected area(s) within the side cut.
FDA Determined
Cause 2
Software design (manufacturing process)
Action Recall notification letters were sent to consignees on April 14, 2016. The letter details precautions to be taken by the surgeon and requests the consignee sign and return an acknowledgement form.
Quantity in Commerce 81 units
Distribution United States, Albania, Australia, Brazil, Chile, Costa Rica, Czech Republic, France, Germany, Greece, Hungary, India, Italy, Romania, Slovakia, Spain, Taiwan, Thailand, Turkey, UAE, Ukraine
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 = OOE and Original Applicant = ALCON LENSX, INC.