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

Model Number	VTICM5_13.2
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Work order search: no similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm vticm5_13.2.-10.5/1.0/092 (sphere/cylinder/axis) implantable collamer lens into the patient's left eye (os) on (b)(6) 2024.The lens tore/broke during injection/delivery into the eye.The lens stuck in cartridge or injection system.There was patient contact(lens touched the eye).No patient injury.The lens was exchanged with a same length lens on (b)(6) 2024.This resolved the problem.Cause of the event is reported as unknown.
Additional Manufacturer Narrative
Correction of information: b5 - reported as; the reporter indicated that the surgeon implanted a 13.2mm vticm5_13.2.-10.5/1.0/092 (sphere/cylinder/axis) implantable collamer lens into the patient's left eye (os) on (b)(6) 2024.The lens tore/broke during injection/delivery into the eye.The lens stuck in cartridge or injection system.There was patient contact (lens touched the eye).No patient injury.The lens was exchanged with a same length lens on (b)(6) 2024.This resolved the problem.Cause of the event is reported as unknown.Correct to: the reporter indicated that a 13.2mm vticm5_13.2.-10.5/1.0/092 (sphere/cylinder/axis) implantable collamer lens for the patient's left eye (os).The lens tore/broke during injection/delivery into the eye.The lens stuck in cartridge or injection system.There was patient contact (lens touched the eye).No patient injury.A new lens was implanted with a same length lens on (b)(6) 2024.This resolved the problem.Cause of the event is reported as unknown.D4: primary unique device identifier (udi)#: reported as: (b)(4) - correct to: (b)(4)."udi related data quality updates only".D6a - reported as: (b)(6) 2024 - correct to: blank (lens not implanted).D6b - reported as: (b)(6) 2024 - correct to: blank (lens not implanted).G3 - reported as (b)(6) 2023 - correct to: (b)(6) 2023.Claim# (b)(4).
Additional Manufacturer Narrative
Additional information: h6- type of investigation 3331 - device history record (dhr) review; dhr review indicates that the product has been manufactured within the established process parameters and that there is no indication that the manufacturing and/or processing of the device contributed to the complaint issue.Claim# (b)(4).
Additional Manufacturer Narrative
Upon further review, it has been determined that the event is not mdr reportable as a serious injury or reportable malfunction has not occurred.Claim# (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 SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 19370972
• Report Number: 2023826-2024-02272
• Device Sequence Number: 20737784
• Product Code: QCB
• UDI-Device Identifier: 00840311311194
• UDI-Public: 00840311311194
• 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: 2024
• Device Explanted Year: 2024
• 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,Followup
• Report Date (Section B): 05/01/2024

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: 07/31/2026
• Device Model Number: VTICM5_13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2024
• Supplement Date Received by Manufacturer: 09/25/2024; 03/04/2025; 05/31/2025
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 09/26/2024; 04/02/2025; 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/07/2023
• 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, LOT#UNK.; FOAMTIPPLUNGER MODEL#FTP, LOT#UNK.; INJECTOR MODEL#MSI-PF, LOT#UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR
• Patient Sex: Male