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

Model Number	MICL13.2
Medical Device Problem Codes	Difficult To Position (1467); Inadequacy of Device Shape and/or Size (1583); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	04/07/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter stated the surgeon inserted a 13.2mm micl13.2 implantable collamer lens, -5.0 diopter, and noted the lens was too long for the patient's eye.The lens was removed within the same surgery with no patient injury.Another lens was not implanted.The surgeon felt the lens may have been mislabeled.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Additional information received - the reporter indicated the lens was inserted and removed from the left eye (os).The incision was enlarged to remove the lens and sutures were required to close the incision.The reporter indicated the icl would not position correctly and kept rotating out of position.During removal, the icl caught the iris which caused depigmentation and atrophy temporally.The patient experienced photosensitivity.
Additional Manufacturer Narrative
Method: 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, medical review, 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: 5654689
• Report Number: 2023826-2016-00639
• Device Sequence Number: 18896373
• Product Code: MTA
• UDI-Device Identifier: 00841542103190
• UDI-Public: (01)00841542103190(17)171031
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 10/31/2017
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/12/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/13/2016
• Supplement Report FDA Received Date: 07/01/2016; 12/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 YR