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

Model Number	VICMO 13.2 (- 14.50)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Iritis (1940); Uveitis (2122); Blurred Vision (2137)
Date of Event	06/26/2025
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.H11: manufacture narrative: secondary surgical intervention to remove/replace/reposition the lens is identified in the labeling as a known potential adverse event following icl implantation.H11: manufacture narrative: uveitis/iritis, iritis is an inflammatory condition which is common after intra-ocular surgery, however this is usually mild and does not require any additional interventions beyond the standard post-op regimen.In some cases, the degree of inflammation may be more severe and require extended steroid treatment.Procedural factors including excessive surgical manipulation and the use of pro-inflammatory substances in the eye may have contributed to the event.Mechanical insult to the iris can result in a prolonged or stronger inflammatory response.An exact cause could not be determined as the event could be multifactorial in nature including patient and/or procedure related factors.Claim #: (b)(4).
Event or Problem Description
A facility representative reported that following an implantable collamer lens (icl) implantation procedure the patient experienced excessive vault, significant reduction of irido-corneal angles, significant shallowing of the ac, blurred vision, uveitis/iritis.Treatment performed.Ac inflammation.Medication administered.Iris atrophy and the lens was exchanged for a shorter length lens and problem resolved.The cause of event was reported as other, "wrong size lens calculation.".
Additional Manufacturer Narrative
H6- method code 3331: device history record (dhr) review: based on the results of the investigation, all released devices from the associated work orders(s), including the suspected device, have been manufactured within established 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 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: 22841665
• Report Number: 2023826-2025-01190
• Device Sequence Number: 15818475
• Product Code: MTA
• UDI-Device Identifier: 00840311302505
• UDI-Public: (01)00840311302505(11)250513(17)280430
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2025

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: VICMO 13.2 (- 14.50)
• Device Catalogue Number: VICMO 13.2
• Device Lot Number: N/A
• 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: 07/25/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 10/15/2025
• Date Device Manufactured: 05/13/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 24 YR
• Patient Sex: Female