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

Model Number MICL13.2

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 12/15/2017

Event Type  malfunction  

Manufacturer Narrative

Work order search: no similar complaint type events were reported for units within the same lot.(b)(4).

Event Description

The reporter indicated that the surgeon noticed microscopic black flakes on a micl13.2, -8.0 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 a wek-cell 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.

Manufacturer Narrative

Corrected data: (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: cynthia thai ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 7188509
• MDR Text Key: 97750374
• Report Number: 2023826-2018-00066
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542103251
• UDI-Public: 00841542103251
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Physician
• Device Expiration Date: 01/31/2019
• Device Model Number: MICL13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/18/2017
• Initial Date FDA Received: 01/12/2018
• Supplement Dates Manufacturer Received: 03/07/2018
• Supplement Dates FDA Received: 03/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1