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)
Date of Event	12/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: product evaluation found that the lens was returned in a specimen cup and an empty cartridge in the cup.Visual inspection found no visible damage to lens.Work order search: 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 microscopic black flakes on a micl13.2, -4.0 diopter, implantable collamer lens when they opened the lens vial and were preparing to load the lens in the cartridge for the injection on (b)(6) 2017.The surgeon described opening the lens vial with hemostats, removing the metal ring, and removing the grey stopper with a sterile gloved hand.The lens was poured out of the vial onto the injector cartridge tray with the assistance of the injector plunger to guide the lens out of the vial.When the lens was picked up with icl loading forceps, the black flakes were noticed.There was no patient contact.They used a new cartridge/injector and a new icl was loaded and used to perform the surgery.

• 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: 7188510
• Report Number: 2023826-2018-00067
• Device Sequence Number: 1447563
• Product Code: MTA
• UDI-Device Identifier: 00841542103176
• UDI-Public: 00841542103176
• 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
• Report Date (Section B): 12/18/2017

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: 10/31/2018
• 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: 01/04/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2017
• Initial Report FDA Received Date: 01/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1