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

Model Number	MICL12.6
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter stated the surgeon noted a substance/residue on a 12.6mm micl12.6 implantable collamer lens, -10.5 diopter, and the lens was not used.There was no patient contact.The backup lens was implanted.
Additional Manufacturer Narrative
Device evaluated by manufacturer?: visual inspection of the returned product found no visible damage to the lens.The lens was returned in liquid.The lens was re-examined under 20x magnification and no defects were detected on the lens.If the substance is now in solution, we cannot isolate it because it is not clear what the particulate is or how it looks like.Method: work order search.Result: a lens work order search was performed and no similar complaints were found.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: 6191976
• Report Number: 2023826-2016-01783
• Device Sequence Number: 955943
• Product Code: MTA
• UDI-Device Identifier: 00841542103039
• UDI-Public: (01)00841542103039(17)171130
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2016

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: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/20/2016
• Supplement Report FDA Received Date: 02/27/2017
• 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 MSI-PF - LOT NUMBER UNK
• Patient Age: 43 YR