LenSx Laser System. Indicated for use in patients undergoing cataract surgery and refractive surgery.
Reported: May 25, 2016 Initiated: April 14, 2016 #Z-1688-2016
Product Description
LenSx Laser System. Indicated for use in patients undergoing cataract surgery and refractive surgery.
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.
Details
- Recalling Firm
- Alcon Research, Ltd.
- Units Affected
- 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
- Location
- Fort Worth, TX
Frequently Asked Questions
What product was recalled? ▼
LenSx Laser System. Indicated for use in patients undergoing cataract surgery and refractive surgery.. Recalled by Alcon Research, Ltd.. Units affected: 81 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 25, 2016. Severity: Moderate. Recall number: Z-1688-2016.
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