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

Model Number	MICL13.2
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer? no: lens not returned.Claim #(b)(4).
Event or Problem Description
The reporter stated the surgeon was advancing a 13.2mm micl13.2 implantable collamer lens, -15.5 diopter, forward from the cartridge with a forcep and the lens tore.There was no patient contact and the backup lens was implanted.The reporter indicated the cause of the event was unknown.
Additional Manufacturer Narrative
Result: visual inspection of the returned product found a piece of one haptic torn off and missing.The lens was returned in vial 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: 5758705
• Report Number: 2023826-2016-00875
• Device Sequence Number: 455639
• Product Code: MTA
• UDI-Device Identifier: 00841542103404
• UDI-Public: (01)00841542103404(17)161231
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 06/22/2016

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: 12/31/2016
• Device Model Number: MICL13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/29/2016
• Supplement Report FDA Received Date: 07/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL: SFC-45 FP - LOT NUMBER: UNK