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

Model Number	MICL12.1
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the lens was returned in liquid in a vial.Visual inspection of the returned product found one haptic torn.(b)(4).
Event or Problem Description
The reporter indicated the surgeon inserted a 12.1mm micl12.1 implantable collamer lens, -13.5 diopter, and the lens was noted to have flipped.The lens was removed within the same surgery with no patient injury, no enlarged incision or sutures.The iris had come down so the surgeon decided to bring the patient back on (b)(6) 2017 to implant the backup lens.The reporter indicated the cause of the event was unknown.The reporter indicated they used another manufacturers injector system with this model lens and this is off-label use.
Additional Manufacturer Narrative
Previous: the reporter indicated they used another manufacturers injector system with this model lens and this is off label use.Corrected: by the reporter clarification that the staar injection system was used.(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: 6595991
• Report Number: 2023826-2017-00840
• Device Sequence Number: 802133
• Product Code: MTA
• UDI-Device Identifier: 00841542102827
• UDI-Public: (01)00841542102827(17)180430
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 05/03/2017

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: 04/30/2018
• Device Model Number: MICL12.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/03/2017
• Supplement Date Received by Manufacturer: 09/12/2017
• Initial Report FDA Received Date: 05/26/2017
• Supplement Report FDA Received Date: 09/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR