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 Consequences Or Impact To Patient (2199)
Date of Event	07/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Work order search: no similar complaint was reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated the surgeon inserted and removed a 13.2mm micl13.2 implantable collamer lens, -4.5 diopter, within the same surgery due to the lens tore/broke during delivery into the eye.There was no patient injury.A same model/length/diopter lens was implanted within the same surgery and the problem was resolved.
Additional Manufacturer Narrative
Device evaluation: the lens was returned in liquid in a lens vial.Visual inspection found a lens haptic torn off and missing.(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: 8805166
• Report Number: 2023826-2019-01253
• Device Sequence Number: 16223173
• Product Code: MTA
• UDI-Device Identifier: 00841542103183
• UDI-Public: 00841542103183
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2019

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: 05/31/2020
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Initial Date Received by Manufacturer: 07/03/2019
• Supplement Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 07/31/2019
• 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 # UNK; FOAM TIP PLUNGER MODEL FTP - LOT # UNK; INJECTOR MODEL AND LOT # UNK
• Patient Age: 23 YR