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 Patient Involvement (2645)
Date of Event	04/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: lens was returned in liquid, in lens vial.Visual inspection found no visible damage to the lens.Lens has reddish brown colored debris/residue on optic.(b)(4).
Event or Problem Description
The reporter stated that the surgeon removed a 13.2mm micl13.2 implantable collamer lens, -8.5 diopter, from its vial and when rinsing the lens he noted red debris in the middle of the lens optic.There was no patient contact.
Additional Manufacturer Narrative
Method: (materials and chemistry evaluation): the reddish debris found on the lens was sent for analysis to be investigated further using a fourier transform infrared spectroscopy and scanning electron microscopy with energy dispersive x-ray spectroscopy(sem-edx); the particulate consisted of oxidized steel (composed of iron, chromium, and nickel), silicates (sodium, aluminum, potassium, and calcium), and other organic carbonates.Review of the lens manufacturing process and equipment did not find probable causes for the particulate review of the lens manufacturing process and equipment did not find any probable causes for the particulate.Part of the processing, production lenses are visually inspected under magnification twice to help ensure particulates, such as this reddish debris, are detected.Method: (device from same lot evaluated): a lens work order search was performed.No other similar complaints found.(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: 6586265
• Report Number: 2023826-2017-00870
• Device Sequence Number: 624145
• Product Code: MTA
• UDI-Device Identifier: 00841542103268
• UDI-Public: (01)00841542103268(17)181231
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2017

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: 12/31/2018
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/24/2017
• Supplement Date Received by Manufacturer: 08/04/2017
• Initial Report FDA Received Date: 05/23/2017
• Supplement Report FDA Received Date: 08/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1