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

Model Number	MICL13.2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter stated the surgeon implanted a 13.2mm micl13.2 implantable collamer lens, -8.5 diopter, in the patient's right eye (od) on (b)(6) 2017.The lens was explanted on (b)(6) 2017 due to aniseikonia with contact lens intolerance.The patients post-op bscva was 20/20.The reporter indicated the event was not product related.
Additional Manufacturer Narrative
Device evaluation: visual inspection of the returned product found one haptic torn.The lens was returned dry and there was evidence of dark and clear residue on the lens.Work order search: no similar complaints were reported for units within the same lot.(b)(4).
Additional Manufacturer Narrative
Additional data: concomitant medical products - cartridge model sfc-45 fp - lot number unk.Corrected data: device available for evaluation? - previous date is incorrect, correct date is 02/08/2017.(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: 6341613
• Report Number: 2023826-2017-00243
• Device Sequence Number: 13695321
• Product Code: MTA
• UDI-Device Identifier: 00841542103268
• UDI-Public: (01)00841542103268(17)181130
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 11/30/2018
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/27/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/17/2017
• Supplement Report FDA Received Date: 03/23/2017; 03/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention