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

Model Number	VICM5_12.6 -06.00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Endophthalmitis (1835)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6-investigation type 4110: lens work order search- no similar complaint event(s) within associated lots were found.Claim # (b)(4).
Event or Problem Description
A facility representative reported that an implantable collamer lens (icl) was implanted as an exchange lens and the patient experienced endophthalmitis, blurred vision.It was noted that medication was administered.In a separate visit the lens was explanted.There are multiple medical device reports associated with this patient.This report is 1 of 2 total reports.Based on the information provided, the risk assessment for our product, and our experience, we have determined the cause or contribution to the reported issue is not indicative of a manufacturing related issue or product deficiency.".
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: 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 SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 24236413
• Report Number: 2023826-2026-00167
• Device Sequence Number: 10269763
• Product Code: MTA
• UDI-Device Identifier: 00840311300525
• UDI-Public: (01)00840311300525(11)251104(17)281031
• 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: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2026

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_12.6 -06.00
• Device Catalogue Number: VICM5_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: 01/26/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 04/11/2026
• Date Device Manufactured: 11/04/2025
• 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 Sex: Unknown