MAUDE Adverse Event Report: STAAR SURGICAL COMPANY ICL (IMPLANTABLE COLLAMER LENS); INTRAOCULAR LENS

Model Number	MICL12.6
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/02/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Method - work order search.Results - a lens work order search was performed and no similar complaints were found.Visual inspection of the returned product found a piece of one haptic torn off and missing.The lens was returned dry and there was evidence of white residue on the lens surface.Conclusion - based on the complaint history, work order search and the evaluation of the returned product, a specific root cause of the event could not be determined.(b)(4).
Event or Problem Description
The reporter stated a 12.6mm micl12.6 implantable collamer lens, -13.5 diopter, was removed from the lens vial and the surgeon was preparing to load the lens.A black speck was noted on the lens and the surgeon decided not to use it.There was no patient contact and the backup lens was implanted.
Additional Manufacturer Narrative
Based on the dhr review and root cause analysis, the probable cause could not be determined at this time.There were no documented issues and concerns with the manufacturing and inspection processes which may cause particulates on the lens or release of nonconforming lens.Physician report does not indicate that any adverse event or condition would have caused the complaint issue.Based on the complaint history, work order search, product evaluation, and device history record review, a specific root cause of the event could not be determined.(b)(4).

• Brand Name: ICL (IMPLANTABLE COLLAMER LENS)
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 5392219
• Report Number: 2023826-2016-00105
• Device Sequence Number: 471183
• Product Code: MTA
• UDI-Device Identifier: 00841542103091
• UDI-Public: (01)00841542103091(17)160229
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Followup
• Report Date (Section B): 12/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 02/29/2016
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/26/2016
• Supplement Report FDA Received Date: 03/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1