Alcon Research, Ltd.: Medical Device Recall in 2016 - (Recall #: Z-1688-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

LenSx Laser System. Indicated for use in patients undergoing cataract surgery and refractive surgery.

Product Classification:

Class II

Date Initiated: April 14, 2016

Date Posted: May 25, 2016

Recall Number: Z-1688-2016

Event ID: 73883

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.

Status: Terminated

Product Quantity: 81 units

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

Distribution Pattern:

United States, Albania, Australia, Brazil, Chile, Costa Rica, Czech Republic, France, Germany, Greece, Hungary, India, Italy, Romania, Slovakia, Spain, Taiwan, Thailand, Turkey, UAE, Ukraine

Voluntary or Mandated:

Voluntary: Firm initiated