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	07/19/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection of the returned product found the lens returned inside a cartridge.There was no visible damage to the cartridge.There was evidence of clear surgical residue.Based on the complaint history, work order search 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 loaded a 13.2mm micl13.2 implantable collamer lens, -6.5 diopter, but the lens would not load correctly and was torn.There was no patient contact.Another same model and diopter lens was implanted.The reporter was unable to provide any additional information.

• 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: 5880926
• Report Number: 2023826-2016-01100
• Device Sequence Number: 1136655
• Product Code: MTA
• UDI-Device Identifier: 00841542103220
• UDI-Public: (01)00841542103220(17)180131
• 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
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/20/2016

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: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2016
• Initial Report FDA Received Date: 08/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 32 YR