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

Model Number	MICL13.2
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens was returned dry in a piece of gauze.Visual inspection of the returned product found one haptic torn, with a piece torn off and missing.There was evidence of clear surgical residue and debris.(b)(4).
Event or Problem Description
The reporter stated the surgeon inserted a 13.2mm micl13.2 implantable collamer lens, -4.5 diopter, and the lens flipped in the eye.The lens was cut in half to remove and there was no patient injury.The back up lens was implanted with no issues.The reporter stated the cause of the event was unknown.
Additional Manufacturer Narrative
Additional data: the reporter stated the surgeon inserted a 13.2mm micl 13.2 implantable collamer lens, -4.5 diopter, serial # (b)(4), and the lens flipped in the eye.The lens was cut in half to remove and there was no patient injury.The backup lens, serial # (b)(4), was implanted with no issues.The reporter stated the cause of the event was unknown.Corrected data: (b)(4).
Additional Manufacturer Narrative
Work order search: no similar complaint was reported for units within the same lot.Claim # (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: 6832456
• Report Number: 2023826-2017-01380
• Device Sequence Number: 44731
• Product Code: MTA
• UDI-Device Identifier: 00841542103183
• UDI-Public: 00841542103183
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 08/02/2017

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: 10/31/2018
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/02/2017
• Supplement Date Received by Manufacturer: 11/09/2017; 11/30/2017
• Initial Report FDA Received Date: 08/30/2017
• Supplement Report FDA Received Date: 11/21/2017; 11/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1