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

Model Number	MICL13.2
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon noticed a microscopic black speck on a micl13.2, -9.5 diopter, implantable collamer lens.The lens was poured out of the vial into the packaging of the cartridge and that's when the speck was noticed.It was reported that the icl had touched nothing but the plunger which was directly opened and used to slide the icl out.The speck was located on the surface of the lens.
Additional Manufacturer Narrative
Device evaluation: the lens was returned in liquid, in a lens case/vial.Visual inspection found no visible damage to the lens.The lens was inspected under 20x on the microscope and no black spec was noted.Claim # (b)(4).

• 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: 7208090
• Report Number: 2023826-2018-00133
• Device Sequence Number: 896164
• Product Code: MTA
• UDI-Device Identifier: 00841542103282
• UDI-Public: 00841542103282
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2017

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: 04/30/2018
• Device Model Number: MICL13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/20/2017
• Supplement Date Received by Manufacturer: 07/03/2018
• Initial Report FDA Received Date: 01/19/2018
• Supplement Report FDA Received Date: 08/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1