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

Model Number	MICL12.6
Medical Device Problem Codes	Positioning Failure (1158); Torn Material (3024)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection of the returned product found one haptic torn, with pieces torn off and missing.The lens was returned in liquid.(b)(4).
Event or Problem Description
The reporter stated the surgeon was inserting a 12.6mm micl12.6 implantable collamer lens, -8.5 diopter, and noted the lens was damaged.The lens was partially inserted and was removed with no patient injury.The backup lens was implanted.The reporter stated the lens may not have been pulled down the cartridge barrel enough and the foam tip plunger caught and damaged the lens.The reporter stated the cause of the event was due to user error.

• Brand Name: ICL (IMPLANTABLE COLLAMER LENS)
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 6064990
• Report Number: 2023826-2016-01560
• Device Sequence Number: 16360811
• Product Code: MTA
• UDI-Device Identifier: 00841542102995
• UDI-Public: (01)00841542102995(17)180430
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/13/2016

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: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2016
• Initial Report FDA Received Date: 10/28/2016
• 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
• Patient Age: 36 YR