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

Model Number	MICL13.2
Medical Device Problem Code	Misfocusing (1401)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 implanted a 13.2mm micl13.2 implantable collamer lens, -05.00 diopter, in the patients left eye (os) on (b)(6) 2020.The lens was explanted on (b)(6) 2021 due to patient experienced a refractive surprise and monocular diplopia (double vision).The lens was exchanged for a toric icl lens and the problem was resolved.The cause of the event was unknown, there was some residual refractive error, but even with glasses the patient had monocular diplopia, very small peripheral pi unlikely cause.The eye is normal and acuity and symptoms improved.
Additional Manufacturer Narrative
H3 - device evaluation: lens was returned in a micro-centrifuge vial in liquid.Visual inspection found no visible damage to the lens.Claim#: (b)(4).
Additional Manufacturer Narrative
H3 - device evaluation: lens was returned in a micro-centrifuge vial in liquid.Visual inspection found no visible damage to the lens.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: 11478820
• Report Number: 2023826-2021-00634
• Device Sequence Number: 3430681
• Product Code: MTA
• UDI-Device Identifier: 00841542103190
• UDI-Public: 00841542103190
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 07/06/2021; 07/06/2021
• Initial Report FDA Received Date: 03/14/2021
• Supplement Report FDA Received Date: 07/06/2021; 07/13/2021
• 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 # 1495756; INJECTOR MODEL AND LOT # UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR