MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC VISX EXCIMER LASER

Model Number STAR S4 IR

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Code Available (3191)

Event Date 09/14/2011

Event Type  Injury  

Event Description

The clinic reported that a pt treated for a laser vision enhancement procedure approx 4 years earlier presented with an epithelial ingrowth in the right eye. The epithelial ingrowth was removed on (b)(6) 2011. The pt returned on (b)(6) 2011 for a f/u examine due to experiencing blurriness in their right eye. The pt was diagnosed with a recurring epithelial ingrowth. The surgeon lifted the flap and removed the ingrowth. This is a recurring event for this pt and a similar event was reported on (b)(6) 2011 in medwatch 3006695864-2011-00058.

Manufacturer Narrative

(b)(4). Epithelial ingrowth. No clinical support or service was requested. Customer reporting incident only. All pertinent info available to amo has been submitted. Should new info that changes the facts and/or conclusion of this report become available, a supplemental report will be submitted.

• Brand Name: VISX EXCIMER LASER
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 92705 493
• Manufacturer (Section G): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 92705 493
• Manufacturer Contact: carol kail ; 1700 e st andrew place; santa ana, CA 92705-4933 ; 7142478598
• MDR Report Key: 2339383
• MDR Text Key: 2363141
• Report Number: 3006695864-2011-00109
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K000327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User facility
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Type of Report: Initial
• Report Date: 09/29/2011

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 10/24/2011
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: STAR S4 IR
• Device Catalogue Number: 0030-1479
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Outpatient Treatment Facility
• Date Report TO Manufacturer: 09/29/2011
• Date Manufacturer Received: 09/29/2011
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 08/01/1999
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient TREATMENT DATA

Date Received: 10/24/2011 Patient Sequence Number: 1