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

Model Number	VTICM5_13.2 (-10.50/1.5)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intraocular Pressure Increased (1937)
Date of Event	08/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Iop elevation from baseline is identified in the labeling as a known potential adverse event following icl implantation.(b)(4).
Event or Problem Description
A facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced elevated iop with nearly pupil block.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Additional information: b5-a facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced elevated iop with nearly pupil block.Medication was prescribed.The lens remains implanted.If additional information is received a supplemental medwatch report will be submitted.H6-investigation type 4110: lens work order search- no similar complaint event(s) within associated lots were found.Claim# (b)(4).
Additional Manufacturer Narrative
Additional information: b3 is 28-aug-2025.Claim# (b)(4).
Additional Manufacturer Narrative
B5- a facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced elevated iop with pupil block, unreactive fixed pupil (urrets-zavalia-syndrome) medication was prescribed.The lens was explanted.D6b- (b)(6) 2025.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).

• Brand Name: EVO/EVO+ VISIAN IMPLANTABLE COLLAMER LENS
• 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 muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 22907566
• Report Number: 2023826-2025-01252
• Device Sequence Number: 21036248
• Product Code: QCB
• UDI-Device Identifier: 00840311311477
• UDI-Public: (01)00840311311477(11)250310(17)280229
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/27/2025

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_13.2 (-10.50/1.5)
• Device Catalogue Number: VTICM5_13.2
• 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: 08/21/2025
• Supplement Date Received by Manufacturer: 08/29/2025; 08/30/2025; 10/07/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 08/29/2025; 09/23/2025; 10/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/10/2025
• 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 (FTP), LOT# UNK.; INJECTOR MODEL: MSI-PF, LOT# UNK.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 32 YR
• Patient Sex: Male