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

Model Number	MICL13.2
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/18/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Method: lens work order search.Results: a lens work order search was performed and no similar complaints were found.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 removed and inspected a 13.2mm micl13.2 implantable collamer lens, -7.0 diopter, prior to loading, and noted there was something wrong with the lens.The lens was not used and there was no patient contact.The backup lens was implanted.The reporter stated the surgeon felt the lens was defective but was unable to provide what the defect was.
Additional Manufacturer Narrative
Visual inspection of the returned product found no visible damage to the lens.The lens was returned in liquid.(b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 6378775
• Report Number: 2023826-2017-00324
• Device Sequence Number: 674167
• Product Code: MTA
• UDI-Device Identifier: 00841542103237
• UDI-Public: (01)00841542103237(17)180531
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2016

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: 05/31/2018
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2017
• Supplement Report FDA Received Date: 03/23/2017
• 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: CARTRIDGE MODEL AND LOT NUMBER UNK; INJECTOR MODEL AND LOT NUMBER UNK