MAUDE Adverse Event Report: STAAR SURGICAL 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	11/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced refractive surprise and glare/haloes.In a separate visit the lens was explanted.Cause of the event was reported as device.Additional information was requested.No further information is available at this time.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
H6 - type of investigation - lens work order search: no similar complaint type events reported for units within the same lot.Manufacturer narrative - each lens is subjected to a 100% assessment of the power (spherical and cylinder) and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Significant glare and/or halos (under night driving conditions) and secondary surgical intervention to remove the lens are identified in the labeling as known potential adverse events following icl implantation.Claim # (b)(4).
Additional Manufacturer Narrative
B5- per updated information the explant resolved the refractive surprise and glare/haloes issue.Claim # (b)(4).
Additional Manufacturer Narrative
H6- device evaluation: lens was returned dry in microcentrifuge vial.Visual inspection found significant damage to the lens.The optic and haptics were found deformed.Dimensional inspection found the lens to be within specifications.Functional inspection found the power and cylinder to be within specifications, but the axis was out of specification.H6- 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 the established process parameters and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.Claim # (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 20869191
• Report Number: 2023826-2024-05529
• Device Sequence Number: 15576103
• Product Code: QCB
• UDI-Device Identifier: 00840311308927
• UDI-Public: (01)00840311308927(11)231108(17)261031
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/21/2025

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
• 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: 11/12/2024
• Supplement Date Received by Manufacturer: 12/10/2024; 03/05/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 02/24/2025; 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2023
• 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: INJECTOR MODEL: MSI-PF, LOT# UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female