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

Model Number	VTICM5_13.7
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6 - work order search: no similar complaint type events were reported for units within the same lot.Claim# (b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.7mm vticm5_13.7, -7.0/1.0/130 (sphere/cylinder/axis), implantable collamer lens into the patient's right eye (od) on (b)(6) 2023.The lens was explanted on (b)(6) 2023 due to elevated iop(69mmhg without pupil block and angle closure, and excessive vault.This resolved the problem.Cause of the event is reported as other: lens too big.
Additional Manufacturer Narrative
H6 - health effect clinical code: 4581 (iris compromise).H3 - device evaluation: the lens was returned in liquid in a microcentrifuge vial.Visual inspection found no visible damage and residue on the lens.Dimensional inspection found the lens to be within specifications.
Additional Manufacturer Narrative
H3 - device evaluation: the lens was returned in liquid in a microcentrifuge vial.Visual inspection found no visible damage to the lens.Dimensional inspection found the lens to be within specifications.

• 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: 18048081
• Report Number: 2023826-2023-04728
• Device Sequence Number: 15328266
• Product Code: QCB
• UDI-Device Identifier: 00840311314485
• UDI-Public: 00840311314485
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 10/13/2023

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: 04/30/2026
• Device Model Number: VTICM5_13.7
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2023
• Supplement Date Received by Manufacturer: 11/27/2023; 01/04/2024
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 12/15/2023; 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2023
• 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#1626239.; FOAMTIPPLUNGER MODEL#FTP,LOT#1646581.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 22 YR
• Patient Sex: Male