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

Model Number	MICL13.2
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by manufacturer? no - lens not returned.(b)(4).
Event or Problem Description
The reporter stated the surgeon implanted a 13.2mm micl13.2 implantable collamer lens, -13.5 diopter, in the patient's right eye (od) on (b)(6) 2016.The lens was explanted due to sizing.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
Result: visual inspection of the returned product found no visible damage to the lens.The lens was returned in liquid.Conclusion: based on the complaint history, work order search and product evaluation, a specific root cause of the event could not be determined.Claim # (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: 5870485
• Report Number: 2023826-2016-01044
• Device Sequence Number: 10866881
• Product Code: MTA
• UDI-Device Identifier: 00841542103367
• UDI-Public: (01)00841542103367(17)180131
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2016

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?: No
• Operator of Device: Physician
• Device Expiration Date: 01/31/2018
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/11/2016
• Supplement Report FDA Received Date: 09/23/2016
• 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: 47 YR