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

Model Number	MICL13.2
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No similar complaint type events were reported for units within the same lot.Lens was returned stuck in the cartridge.Visual inspection found no visible damage to device and white residue on lens.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon loaded a micl13.2, -11.5 diopter, implantable collamer lens, and a tear was noted.There was no patient contact and the backup lens was used.The reporter stated that the cause of event was unknown.
Additional Manufacturer Narrative
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: 7253167
• Report Number: 2023826-2018-00168
• Device Sequence Number: 13707459
• Product Code: MTA
• UDI-Device Identifier: 00841542103329
• UDI-Public: 00841542103329
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2018

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: 02/06/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/10/2018
• Supplement Date Received by Manufacturer: 04/11/2018
• Initial Report FDA Received Date: 02/08/2018
• Supplement Report FDA Received Date: 04/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR