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

Model Number	VTICM5 13.2 (-13.0/1.5)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intraocular Pressure Increased (1937)
Date of Event	11/27/2024
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.The patient experienced excessive vault.Lens remains implanted.Reporter stated iop controlled by medication.Cause of the event is unknown.
Additional Manufacturer Narrative
Claim# (b)(4).See claim# (b)(4) for fellow eye.
Additional Manufacturer Narrative
D1 - brand nameevo/evo+visian implantable collamer lens.D2a - common device name phakic toric intraocular lens.D2b - product code qcb.D4 - model number vticm5 13.2 (-13.0/1.5).D4 - catalog number vticm5 13.2.D4 - s/n (b)(6).D4 - expiration date 07/31/2027.D4 - udi (b)(4).D5 - health professional.E1 - inital reporter: simo vision.G2 - report source: foreign, health professional, other, netherlands.H4 - device manufacture date: 25-aug-2024.Claim (b)(4).Claim# (b)(4) for fellow eye.

• 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 CA 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 800 royal oaks dr.; suite: 210; monrovia, CA 91106 ; 8002927902
• MDR Report Key: 20984218
• Report Number: 2023826-2024-05808
• Device Sequence Number: 18256300
• Product Code: QCB
• UDI-Device Identifier: 00840311311521
• UDI-Public: (01)00840311311521(11)240825(17)270731
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2024

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 (-13.0/1.5)
• 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: 11/28/2024
• Supplement Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 12/19/2024
• Supplement Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/25/2024
• 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: Other
• Patient Age: 46 YR
• Patient Sex: Female