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

Model Number	MICL12.6
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Device Operates Differently Than Expected (2913); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection of the returned product found no visible damage to the lens.The lens was returned in liquid.No similar complaints were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated the surgeon inserted a 12.6mm micl12.6 implantable collamer lens, -6.5 diopter, but the lens would not unfold.The lens was removed within the same surgery, with no patient injury.Upon removal, the lens haptic was noted to be curved and bent upwards.The backup lens was implanted.The reporter indicated the cause of the event may have been due to aggressive manipulation in order to get the lens to unfold.

• 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: 6444891
• Report Number: 2023826-2017-00520
• Device Sequence Number: 501070
• Product Code: MTA
• UDI-Device Identifier: 00841542102957
• UDI-Public: (01)00841542102957(17)181031
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/08/2017

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: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2017
• Initial Report FDA Received Date: 03/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL SFC-45 FP - LOT NUMBER UNK; FOAM TIP PLUNGER MODEL FTP - LOT NUMBER UNK; INJECTOR MODEL AND LOT NUMBER UNK