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

Model Number	MICL12.6
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lens was returned stuck in sfc-25 cartridge.Cartridge was returned in device tray with clear residue.Visual inspection found no visible damage to the device, residue on lens and the lens stuck in the cartridge.A lens work order search was performed.No other similar complaint type event found.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon loaded a 12.6mm micl12.6, implantable collamer lens, -11.5 diopter, and the lens ripped.There was no patient contact.The back up lens was used with no issues.The reporter stated that the cause of event was unknown.
Additional Manufacturer Narrative
Corrected data concomitant medical products: cartridge model no.: sfc-25 and cartridge lot no.: 1380994.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: 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: 7382965
• Report Number: 2023826-2018-00488
• Device Sequence Number: 1232895
• Product Code: MTA
• UDI-Device Identifier: 00841542103053
• UDI-Public: 00841542103053
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/01/2018

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: 09/30/2019
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/01/2018
• Supplement Date Received by Manufacturer: 05/30/2018; 06/01/2018
• Initial Report FDA Received Date: 03/29/2018
• Supplement Report FDA Received Date: 05/31/2018; 06/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1