MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER OPHTHALAS 532 EYELITE LASER SYSTEM; POWERED LASER SURGICAL INSTRUMENT

Catalog Number 8065500001

Device Problem Output below Specifications (3004)

Patient Problem No Patient Involvement (2645)

Event Date 08/06/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when addition reportable information becomes available.The manufacturer internal reference number is: (b)(4).

Event Description

A service technician reported experiencing low laser power during preventive maintenance.There was no patient involvement.

Manufacturer Narrative

The system was examined.It was noticed that the system had low power above 500mw.The customer was informed that the system will not perform above 500mw.No additional, related information was obtained.Therefore, the reported event could not conclusively be determined.The laser was manufactured on may 14th,1999.Based on qa assessment, the product met specifications at the time of release.The root cause cannot be determined conclusively.(b)(4).

• Brand Name: OPHTHALAS 532 EYELITE LASER SYSTEM
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5192751
• MDR Text Key: 30348137
• Report Number: 2028159-2015-09199
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: CS
• PMA/PMN Number: K914334
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Service and Testing Personnel
• Device Catalogue Number: 8065500001
• Other Device ID Number: 1.10
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/1999
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other