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

Model Number	MICL13.2
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer - visual inspection of the returned product found pieces of haptic torn off and missing.The lens was returned in liquid.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, work order search and evaluation of the returned product, a specific root cause of the event could not be determined.(b)(4).
Event or Problem Description
The reporter stated the surgeon loaded a 13.2mm micl13.2 implantable collamer lens, -13.0 diopter, but did not like how the lens was sitting in the cartridge, so decided not to use it.There was no patient contact.The backup lens was loaded and implanted with no problem, using the same cartridge.The reporter stated the surgeon felt there was something wrong with the lens, but was unable to identify the problem.

• 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: 6378771
• Report Number: 2023826-2017-00323
• Device Sequence Number: 16338484
• Product Code: MTA
• UDI-Device Identifier: 00841542103350
• UDI-Public: (01)00841542103350(17)180531
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/03/2017

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: 05/31/2017
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2017
• Initial Report FDA Received Date: 03/04/2017
• 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 SFC-45 FP - LOT NUMBER UNK; FOAM TIP PLUNGER MODEL FTP - LOT NUMBER UNK; INJECTOR MODEL AND LOT NUMBER UNK
• Patient Age: 47 YR