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

Model Number	VTICM5_13.2
Medical Device Problem Codes	Misfocusing (1401); Patient-Device Incompatibility (2682); Optical Problem (3001)
Health Effect - Clinical Codes	Inflammation (1932); Blurred Vision (2137); Visual Disturbances (2140); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6 - health effect clinical code: 4581 - whitish plaque/film.H6 - type of investigation: 4110 - lens work order search: no similar complaint type events reported for units within the same lot.Claim# (b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm vicm5_13.2; -5.50 diopter implantable collamer lens into the patient's left eye (os).The surgeon notes the lens has some diffuse whitish plaques/film on the lens, which looks like it's on the posterior surface of the evo lens and not the lens or cornea.The surgeon also indicated there is a bit more inflammation then typical, the whitish film/plaques appear stable, neither increasing or decreasing and there seems to be no continued inflammation.The surgeon also reports glare/haloes, blurred vision, and on (b)(6) 2023 the lens was explanted.On this same date in a separate surgery, a replacement lens of the same length but different model/power was implanted.It was noted "vision improved significantly with exchange".The cause of the event was reported as a patient related factor and noted "suspect this was inflammatory debris/fibring building up on the lens".
Additional Manufacturer Narrative
Additional information: initial mdr is not applicable as there was no device problem, reporter later clarified the issue was directly patient related.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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 16981458
• Report Number: 2023826-2023-01954
• Device Sequence Number: 15171427
• Product Code: QCB
• UDI-Device Identifier: 00841542119320
• UDI-Public: 00841542119320
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2023

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: 09/30/2023
• Device Model Number: VTICM5_13.2
• 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: 04/21/2023
• Supplement Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 05/22/2023
• Supplement Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2022
• 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: INJECTOR MODEL-LIOLI-24, LOT#-UNK.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 35 YR
• Patient Sex: Female