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

Model Number	MICL13.2
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No similar complaint type events reported for units within the same lot.An injector, cartridge, and injector system work order search was performed.No similar complaint type events found.(b)(4).
Event or Problem Description
The reporter indicated that as the surgeon was loading a 13.2mm micl13.2 implantable collamer lens, -13.5 diopter, the lens tore.This occurred on (b)(6) 2019.There was no patient contact with the lens.Reporter states the cause of the event is unknown as normal loading procedure was followed.
Additional Manufacturer Narrative
H3 - device evaluation: lens was returned dry, stuck on tape.Visual inspection found residue on the lens and the lens was returned coiled and unabled to be evaluated.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: 9559348
• Report Number: 2023826-2020-00034
• Device Sequence Number: 11346531
• Product Code: MTA
• UDI-Device Identifier: 00841542103367
• UDI-Public: 00841542103367
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2019

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: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2020
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 02/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL-SFC-45, LOT#-1446792; FOAM TIP PLUNGER MODEL-FTP, LOT#-1450357; INJECTOR MODEL-MSIPF, LOT# 1397764
• Patient Age: 35 YR