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

Model Number	MICL12.6
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/28/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection of the returned product found the lens trapped inside the cartridge.There was no visible damage to the cartridge.(b)(4).
Event or Problem Description
The reporter stated a piece of haptic from a 12.6mm micl12.6 implantable collamer lens, -9.0 diopter, was torn off and trapped inside a cartridge as the surgeon was pulling the lens forward.There was no patient contact and the backup lens was implanted.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch report will be submitted.

• 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: 5817657
• Report Number: 2023826-2016-00978
• Device Sequence Number: 16144478
• Product Code: MTA
• UDI-Device Identifier: 00841542103008
• UDI-Public: (01)00841542103008(17)180131
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/28/2016

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: 01/31/2018
• Device Model Number: MICL12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2016
• Initial Report FDA Received Date: 07/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1