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

Model Number	VTICM5 12.6 (-8.00/1.0)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	04/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: investigation type code: 4110, lens work order search-no similar complaint event(s) within associated lots were found.H11: 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.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).
Event or Problem Description
A facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced a refractive surprise.In a separate surgery the lens was exchanged with the same model/ length; different power and the problem was resolved.The cause of the event was reported as unknown.
Additional Manufacturer Narrative
Corrected data: b4.- '05/01/2025' should be added.B5.- a facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced a refractive surprise.In a separate surgery the lens was exchanged with the same model/ length; different power and the problem was resolved.The cause of the event was reported as unknown.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.D4.Model#: 'vticm5_12.6 (-8.00/1.0).D4.Serial#: '(b)(6)' should be added.D4.Expiration date: '02/28/2027'.D4.- primary unique device identifier (udi)#: '(b)(4)' should be added.H4.- device manufacture date: '03/14/2024' should be added.] 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 enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 22011394
• Report Number: 2023826-2025-00668
• Device Sequence Number: 7984897
• Product Code: QCB
• UDI-Device Identifier: 00840311307784
• UDI-Public: (01)00840311307784(11)240314(17)270228
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2025

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 12.6 (-8.00/1.0)
• Device Catalogue Number: VTICM5_12.6
• 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: 05/01/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 06/09/2025
• Date Device Manufactured: 03/14/2024
• 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: Female