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

Model Number	MICL12.6
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results (operational problem): visual inspection of the returned product found no visible damage to the lens.The lens was returned in liquid.(b)(4).
Event or Problem Description
The reporter stated the surgeon inserted a 12.6mm micl12.6 implantable collamer lens, -8.5 diopter, and the lens would not unfold in the patient's eye.The lens was removed with no patient injury and the backup lens was implanted.
Additional Manufacturer Narrative
Method: (process evaluation): device history record review.Result: (no failure detected): 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: (unable to confirm complaint): based on the complaint history, work order search, product evaluation, medical review 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: 5693629
• Report Number: 2023826-2016-00796
• Device Sequence Number: 452342
• Product Code: MTA
• UDI-Device Identifier: 00841542102995
• UDI-Public: (01)00841542102995(17)171130
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2016

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: 11/30/2017
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/10/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/01/2016
• Supplement Report FDA Received Date: 09/12/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 41 YR