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

Model Number	MICL13.2
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/28/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pt age and weight: unk.Implant and explant dates: unk.Event problem and evaluation codes: results code(s): (operational problem): - visual inspection of the returned product found a piece of one haptic torn off and missing.The lens was returned in liquid.Conclusions code(s): (unable to confirm complaint): based on the complaint history and product evaluation, a specific root cause of the event could not be determined.(b)(4).
Event or Problem Description
The reporter stated the surgeon was inserting a 13.2mm micl13.2 implantable collamer lens, -15.0 diopter, and the lens was torn.The reporter stated it was unknown if there was any patient contact but there was no injury.The backup lens was implanted.

• 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: 5919705
• Report Number: 2023826-2016-01162
• Device Sequence Number: 587057
• Product Code: MTA
• UDI-Device Identifier: 00841542103398
• UDI-Public: (01)00841542103398(17)170630
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 08/02/2016

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: 06/30/2017
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2016
• Initial Report FDA Received Date: 08/31/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1