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

Model Number	VTICM5_12.6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated the surgeon implanted a 12.6mm vticm5_12.6 implantable collamer lens, -12.50/+2.0/073 (sphere/cylinder/axis), in the patients right eye (od), on 19-dec-2023.The patient experienced a refractive surprise and the lens remained implanted.The cause of the event was unknown.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
A4: unk.A5: unk.A6: unk.D6b: unk.H6: work order search: no similar complaint was reported for units within the same lot.Claim # 733997.
Additional Manufacturer Narrative
The lens was removed on (b)(6) 2024.The lens was replaced with another same model/length but different power lens and the problem was resolved.The eye is fine and the patient is happy.Claim #(b)(4).
Additional Manufacturer Narrative
H3: device evaluation - lens was returned in liquid in microcentrifuge vial.Visual inspection found haptic broken and fibre on lens surface.Dimensional and functional inspection found the lens to be within specifications.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 ; 6263037902
• MDR Report Key: 18839339
• Report Number: 2023826-2024-00858
• Device Sequence Number: 18006583
• Product Code: QCB
• UDI-Device Identifier: 00840311308439
• UDI-Public: 00840311308439
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/14/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Model Number: VTICM5_12.6
• 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: 02/14/2024
• Supplement Date Received by Manufacturer: 04/18/2024; 01/28/2025
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 05/10/2024; 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2023
• 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; 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: Female