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

Model Number	MICL13.2
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer? no - lens not returned.(b)(4).Method (process evaluation): work order search.Results (evaluation result): a lens work order search was performed and no similar complaints were found within the work order.Conclusion (unable to confirm complaint): based on the complaint history and work order search, a specific root cause of the event could not be determined.(b)(4).
Event or Problem Description
The reporter stated the surgeon inserted a 13.2mm micl13.2 implantable collamer lens, -7.0 diopter, but the lens did not feel right.The lens was not fully inserted into the patient's eye and was removed with no patient injury, no incision enlargement or sutures.The backup lens was used.The reporter stated there was no problem with the lens or injection system.
Additional Manufacturer Narrative
Method: (process evaluation): device history record review.Result: visual inspection of the returned product found pieces of both haptics torn off and missing.The lens was returned dry and there was evidence of dark residue on the lens surface.(no failure detected): there was not enough detail provided by the complainant to perform a root cause analysis.There were no documented issues and concerns with the manufacturing and inspection processes which may cause damage or not detect a nonconformance of the lens.Physician report does not indicate that any exceptional event or condition during loading and insertion, except the subjective experience.Conclusion: based on the complaint history, work order search, medical review, device history record review and the 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: 5488107
• Report Number: 2023826-2016-00236
• Device Sequence Number: 1344016
• Product Code: MTA
• UDI-Device Identifier: 00841542103237
• UDI-Public: (01)00841542103237(17)171130
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2016

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: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2016
• Supplement Report FDA Received Date: 08/30/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FOAM TIP PLUNGER MODEL FTP - LOT NUMBER UNK
• Patient Age: 27 YR