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

Model Number	MICL12.6
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: no, lens not returned.(b)(4).
Event or Problem Description
The reporter stated a 12.6mm micl12.6 implantable collamer lens, -16.0 diopter, was torn going through the injector.There was no patient contact.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Event problem and evaluation codes: method: device history record review.Result: visual inspection of the returned product found a piece of one haptic torn off and missing.The lens was returned in liquid.Based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within the established process parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.Conclusion: based on the complaint history, work order search, device history record review and product evaluation, 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: 5919701
• Report Number: 2023826-2016-01190
• Device Sequence Number: 13609510
• Product Code: MTA
• UDI-Device Identifier: 00841542103145
• UDI-Public: (01)00841542103145(17)180131
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2016

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: 01/31/2018
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/01/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/31/2016
• Supplement Report FDA Received Date: 12/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1