MAUDE Adverse Event Report: STAAR SURGICAL COMPANY EVO/EVO+ VISIAN IMPLANTABLE COLLAMER LENS; PHAKIC INTRAOCULAR LENS

Model Number	VICM5 13.2 (-11.0)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Endophthalmitis (1835); Hypopyon (1913)
Date of Event	12/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility representative reported that an implantable collamer lens was implanted into the patient's eye on (b)(6) 2025.The patient experienced endophthalmitis which was noted on (b)(6) 2025.Patient had a bilateral sequential surgery.Cultures were performed and results are unknown.Treatment was also performed (medication).The lens was explanted but it was noted the problem is not resolved.
Additional Manufacturer Narrative
H3 - device evaluation is required but has not yet been performed.H6 - type of investigation: 4110 - lens work order search: no similar complaint type events reported for units within the same lot.Manufacturer narrative: secondary surgical intervention to remove/replace/reposition the lens is identified in the labeling as a known potential adverse event following icl implantation.Claim# (b)(4).
Additional Manufacturer Narrative
Additional information: 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: b5: the patient also experienced hypopyon.This should have been included in previous supplemental mdr.Additional information: h3: device evaluation: lens was returned in a microcentrifuge tube, dry with moisture and debris on the product.Visual inspection found the lens haptic torn, debris on the lens.Claim#: (b)(4).

• Brand Name: EVO/EVO+ VISIAN IMPLANTABLE COLLAMER LENS
• Common Device Name: PHAKIC 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: 24060621
• Report Number: 2023826-2026-00076
• Device Sequence Number: 18508227
• Product Code: MTA
• UDI-Device Identifier: 00840311300952
• UDI-Public: (01)00840311300952(11)250403(17)280331
• 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: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/13/2026

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: VICM5 13.2 (-11.0)
• Device Catalogue Number: VICM5 13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2025
• Supplement Date Received by Manufacturer: 01/30/2026; 02/24/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 02/02/2026; 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL-SFC-45, LOT#: UNK.; FOAM TIP PLUNGER MODEL-FTP, LOT#: UNK.; INJECTOR MODEL-MSI-PF, LOT#: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 20 YR
• Patient Sex: Male