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); Visual Disturbances (2140); Halo (2227)
Date of Event	01/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced lens rotation not associated with low vault, glares/haloes and blurred vision.In a separate visit the lens was explanted.On the same day separate surgery a replacement lens of a longer length was implanted and the problem was resolved.The cause of the event was reported as other/unknown.Cause details provided: "despite having a good vault, the lens rotated 90 degrees.I did downsize from the recommended lens due to her wtw, but the vault was within normal limits." it has been noted that the surgeon selected a different lens size than that initially suggested by the icl calculation software.Therefore, there is not enough safety and effectiveness data to support implantation in this patient category.
Additional Manufacturer Narrative
H11- secondary surgical intervention to remove/replace/reposition the lens and halos/glare is identified in the labeling as a known potential adverse event following icl implantation.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: h6- type of investigation code: 4110- lens work order search-no similar complaint event(s) within associated lots were found.Device evaluation: h3 - type of investigation code: 10- device evaluation: the lens was returned in a specimen cup with moisture and residue/ debris on product.Visual inspection found no visible damage with debris on the lens.Claim# (b)(4).
Additional Manufacturer Narrative
Device evaluation/ corrections: h3 - type of investigation code: 10- device evaluation: the lens was returned in a specimen cup with moisture and debris on product.Visual inspection found no visible damage.Dimensional 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 enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 21280121
• Report Number: 2023826-2025-00194
• Device Sequence Number: 15787821
• Product Code: QCB
• UDI-Device Identifier: 00840311308095
• UDI-Public: (01)00840311308095(11)240624(17)270531
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2025

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 Model Number: VTICM5_ 12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• 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: 01/28/2025
• Supplement Date Received by Manufacturer: 04/22/2025; 05/08/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 04/23/2025; 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2024
• 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-LIOLI-24, LOT#-UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 27 YR
• Patient Sex: Female