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 Codes	Blurred Vision (2137); Toxic Anterior Segment Syndrome (TASS) (4469)
Date of Event	01/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 12.6mm vticm5_12.6; -4.5/1.0/109 (sphere/cylinder/axis) implantable collamer lens into the patient's right eye (od) on (b)(6) 2024.The surgeon reports the patient has tass which was noticed on (b)(6) 2024, diagnostics was performed, and steroids were used.Lens remains implanted with a planned replacement.Cause of the event was reported as the device but noted the device did not fail to perform as intended.
Additional Manufacturer Narrative
It was later reported that on (b)(6) 2024 the lens was explanted but the problem was not resolved.The cause of the event is now reported as unknown.The surgeon additionally noted "currently in good condition, plans to reoperate after futher observation.Postoperative 1w deposts on lens and cornea, 2w kp pig (+) with complaint of blurrying, 3w with complaints of blurring.Subsequently patient infected with covid 19 and the lens was removed.Claim#: (b)(4).
Additional Manufacturer Narrative
H6 - type of investigation 3331 - device history record (dhr) review: based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within established process parameters and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: supplemental #3 incorrectly listed the claim as (b)(4), this should be corrected to (b)(4).Claim#: (b)(4).
Additional Manufacturer Narrative
Additional information: b5 - it was later reported that 58 postoperative days inflammatory recovery was observed.There are no abnormalities.Patient's postop corneal endothelial density was 2632.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 ave; monrovia, CA 91016
• MDR Report Key: 18946963
• Report Number: 2023826-2024-01329
• Device Sequence Number: 12599651
• Product Code: QCB
• UDI-Device Identifier: 00840311307715
• UDI-Public: 00840311307715
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 02/28/2024

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_12.6
• 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: Not provided
• Supplement Date Received by Manufacturer: 03/22/2024; 05/23/2024; 08/20/2025; 08/25/2025
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 03/28/2024; 06/10/2024; 08/21/2025; 08/25/2025
• Date Device Manufactured: 08/31/2023
• 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 - LOT#UNK.; INJECTOR MODEL: MSI-PF - LOT#UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 34 YR
• Patient Sex: Female