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

Model Number	VICM5 12.1
Medical Device Problem Codes	Optical Distortion (3000); Optical Problem (3001)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227)
Date of Event	11/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6 - type of investigation - lens work order search: no similar complaint type events reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that a 12.1mm vicm5_12.1 implantable collamer lens of -4.00 diopter was implanted into the patient's right eye (od) on (b)(6) 2023.On 30-nov-2023 the lens was exchanged for a longer lens of the same model and power due to glare/haloes and the problem resolved.Cause of event was unknown.
Additional Manufacturer Narrative
Corrected data: h6: medical device problem code: "3000" should be removed and "3001" should be added.Claim#: (b)(4).
Additional Manufacturer Narrative
Additional data: h6.- type of investigation code (b): 3331- device history record (dhr) review: based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within established process parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.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 ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 18508980
• Report Number: 2023826-2024-00216
• Device Sequence Number: 18174147
• Product Code: MTA
• UDI-Device Identifier: 00840311300150
• UDI-Public: 00840311300150
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 12/20/2023

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: 01/31/2026
• Device Model Number: VICM5 12.1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2023
• Supplement Date Received by Manufacturer: 02/20/2024; 08/22/2025
• Initial Report FDA Received Date: 01/12/2024
• Supplement Report FDA Received Date: 02/20/2024; 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2023
• 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 W/FTP, LOT# UNK.; INJECTOR MODEL: MSI-PF, LOT# UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 28 YR
• Patient Sex: Female