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

Model Number	VICM513.2
Medical Device Problem Code	Misfocusing (1401)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	02/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that a 13.2mm vicm513.2 implantable collamer lens of -11.0 diopter was implanted in the patient's right eye (od) on (b)(6) 2023.On (b)(6) 2023, the lens was removed due to refractive suprise.On (b)(6) 2023, a replacement lens was implanted and the problem was resolved.Cause of the event is other.
Additional Manufacturer Narrative
A4-a6:unk.H6: work order search: no similar complaints within associated lots were found.(b)(4).
Additional Manufacturer Narrative
Additional data: h3 - device evaluation: the lens was returned in liquid in a microcentrifuge vial.Visual inspection found the haptic broken.Dimensional and functional inspection found the lens to be within specifications.Claim# (b)(4).
Additional Manufacturer Narrative
B5: the reporter indicated that a 13.2mm vicm513.2 implantable collamer lens of -11.0 diopter was implanted in the patient's right eye (od) on (b)(6) 2023.On (b)(6) 2023, the lens was explanted due to refractive surprise.On (b)(6) 2023, a replacement lens was implanted of different power and the problem was resolved.Cause of the event is other and surgeon reports "wrong calculation mistake done by a doctor".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
• Manufacturer (Section G): STAAR SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 800 royal oaks dr. suite# 210; monrovia 91016 ; 6263037902
• MDR Report Key: 17971404
• Report Number: 2023826-2023-04572
• Device Sequence Number: 7007177
• Product Code: MTA
• UDI-Device Identifier: 00840311300952
• UDI-Public: 00840311300952
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/13/2023

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: 08/31/2025
• Device Model Number: VICM513.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2023
• Supplement Date Received by Manufacturer: 11/24/2023; 01/25/2024
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 12/28/2023; 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL: SFC-45 - LOT# UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR
• Patient Sex: Male