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

Model Number	VTICMO13.2
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	06/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that a 13.2mm vticmo13.2 implantable collamer lens of -14.50/+2.5/045 (sphere/cylinder/axis) was implanted into the patient's left eye (os) on (b)(6) 2023.On (b)(6) 2023 lens repositioning was performed due to lens rotation not associated to a low vault but the problem did not resolve, lens continues to rotate.Lens remains implanted.For cause details the reporter states that the lens may be a small size for the patients eye.
Additional Manufacturer Narrative
H6 - type of investigation - lens work order search: no similar complaint type events reported for units within the same lot.Claim# (b)(4).
Additional Manufacturer Narrative
B5 lens exchanged with longer length lens and problem was resolved.(b)(4).
Additional Manufacturer Narrative
H3: device evaluation lens was returned in microcentrifuge vial dry with residue/debris on product.Visual inspection found haptic bent.Dimensional inspection found the lens to be within specification.(b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC TORIC 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
• MDR Report Key: 18170905
• Report Number: 2023826-2023-05149
• Device Sequence Number: 12665049
• Product Code: QCB
• UDI-Device Identifier: 00840311327799
• UDI-Public: 00840311327799
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/23/2023

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: 11/30/2025
• Device Model Number: VTICMO13.2
• 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: 10/23/2023
• Supplement Date Received by Manufacturer: 10/11/2024; 11/11/2024
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 11/05/2024; 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2022
• 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 W/FTP, LOT# UNK.; INJECTOR MODEL: MSI-PF, LOT# UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR
• Patient Sex: Male