MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS; 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	08/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter indicated that as the surgeon attempted to implant a 13.2mm micl13.2 diopter -9.5 implantable collamer lens into the patient's eye, the lens tore.Reportedly, the doctor noticed the tear as it occurred while he was pulling it through the injection cartridge.It was not implanted, and it did not touch the patient's eye.The surgeon then implanted a lens of the same size, model, and diopter.This occurred on (b)(6) 2017.
Additional Manufacturer Narrative
Additional information: work order search: no similar complaint type events were reported for units within the same lot.Corrected data: device evaluation: should have been recorded on supplemental #1.The delivery system was returned in a device tray.There was clear surgical residue/debris on product.Visual inspection found no visible damage to the device, lens having foreign material on device (white residue on cartridge), and lens stuck in cartridge.Claim #: (b)(4).
Additional Manufacturer Narrative
Device evaluation: the lens was returned stuck in cartridge.Visual inspection found the lens returned in cartridge.Claim # (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS
• Common Device Name: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 6899554
• Report Number: 2023826-2017-01514
• Device Sequence Number: 16362046
• Product Code: MTA
• UDI-Device Identifier: 00841542103282
• UDI-Public: 00841542103282
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/31/2017

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: 02/28/2019
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/31/2017
• Supplement Date Received by Manufacturer: 10/10/2017; 11/09/2017
• Initial Report FDA Received Date: 09/27/2017
• Supplement Report FDA Received Date: 10/25/2017; 11/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR