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

Model Number	MICL12.6
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/09/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by manufacturer: no, lens not returned.Method: work order search.Results: a lens work order search was performed and no similar complaints were found within the work order.Conclusion: 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 12.6mm micl12.6 implantable collamer lens, -13.5 diopter, and the lens was noted to be upside down in the patient's eye.The surgeon had some difficulty removing the lens during the same surgery but there was no patient injury.The surgeon decided not to implant another micl lens at that time and the surgery was aborted.Another micl lens was implanted at a later date with no problem and the patient is doing well.
Additional Manufacturer Narrative
Upon review of the device history record, there is nothing in the manufacturing, inspection and packaging process records to suggest a contributory factor to the complaint.Based on the complaint history, work order search, product evaluation, and device history record review, a specific root cause of the event could not be determined.(b)(4).
Additional Manufacturer Narrative
Result: (operational problem) : visual inspection of the returned product found one haptic torn, with a piece torn off and missing.The lens was returned in liquid.(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: 5553065
• Report Number: 2023826-2016-00414
• Device Sequence Number: 272799
• Product Code: MTA
• UDI-Device Identifier: 00841542103091
• UDI-Public: (01)00841542103091(17)160831
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/09/2016

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: 08/31/2016
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/09/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/06/2016
• Supplement Report FDA Received Date: 04/21/2016; 06/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 21 YR