MAUDE Adverse Event Report: ZIEMER GROUPFEMTO LDVFEMTOSECOND LASER

Event Date 05/01/2010

Event Type  Injury   Patient Outcome  Other,Disability,Required Intervention

Event Description

Lasik eye surgery. Abstract of case report published online. (b)(4) idiopathic peripheral necrotizing keratitis after femtosecond laser in situ keratomileusis. J cataract refract surg on (b)(6) 2012. The authors report a case of necrotizing peripheral keratitis after lasik using the femto ldv femtosecond laser in a (b)(6) with no history of medical or ocular disease. The severe peripheral flap inflammation resulted in stromal necrosis. Published photographs reveal a "scalloped appearance" at the flap margin where the cornea melted in both eyes. (b)(6), md of (b)(6) laser vision in (b)(6) is named as the surgeon (b)(6).

• Brand Name: FEMTO LDV
• Type of Device: FEMTOSECOND LASER
• Manufacturer (Section F): ZIEMER GROUP
• Manufacturer (Section D): ZIEMER GROUP
• Device Event Key: 2518767
• MDR Report Key: 2493072
• Event Key: 2389805
• Report Number: MW5024639
• Device Sequence Number: 1
• Product Code: GEX
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/10/2012

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 02/10/2012
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available For Evaluation?: Yes
• Is The Reporter A Health Professional?: No
• Was The Report Sent To Manufacturer?: No
• Is the Device an Implant?: No

Is this an Explanted Device?