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

Model Number	VICM5_12.6
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923); Optical Problem (3001)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Visual Disturbances (2140); Halo (2227)
Date of Event	10/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6 - work order search: no similar complaint was reported for units within the same lot.Claim#: (b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 12.6mm vicm5_12.6 implantable collamer lens, -09.50 diopter, into the patients right eye (od) on (b)(6) 2023.The lens was removed on (b)(6) 2023 due to low vaulting, elevated intraocular pressure (iop), lens dislocation/subluxation and glare/halos.The lens was repositioned on (b)(6) 2023 but the problem was not resolved and the lens was removed.The lens was replaced with a longer lens and the problem was resolved.Cause of the event was the device.

• 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 SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 18632502
• Report Number: 2023826-2024-00277
• Device Sequence Number: 12721361
• Product Code: MTA
• UDI-Device Identifier: 00840311300594
• UDI-Public: 00840311300594
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/12/2024

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: 10/31/2025
• Device Model Number: VICM5_12.6
• 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: 01/12/2024
• Initial Report FDA Received Date: 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/07/2022
• 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.; FOAM TIP PLUNGER MODEL FTP - LOT # UNK.; INJECTOR MODEL MSI-PF - LOT # UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Male