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

Model Number	VTICM5_ 13.2 (-13.50/ 1.50)
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Claim# (b)(4).
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 unkown.
Additional Manufacturer Narrative
H4 - manu date claim# (b)(4).
Additional Manufacturer Narrative
B2 - required intervention to prevent permanent impairment/damage claim# (b)(4).
Additional Manufacturer Narrative
Additional information: b5.- a facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced excessive vault and significant reduction of iridocorneal angles.Reportedly, "iop controlled by medication".Medication was prescribed.Lens remains implanted.D1.- brand name: "evo/evo+ visian implantable collamer lens" should be added.D4.Serial#: "(b)(6)" should be removed."(b)(6)" should be added.D4.- expiration date: "03/31/2027" should be removed."06/30/2027" should be added.D4.Primary unique device identifier (udi)#: "(b)(4)" should be removed."(b)(4)" should be added.H6.-health effect- clinical code (e): "4581- significant reduction of iridocorneal angles" should be added.H6.- medical device problem code (a): "3189" should be removed."2993" should be added.H6- investigation type code: "4110- lens work order search-no similar complaint event(s) within associated lots were found" 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 muniz ; 800 royal oaks dr.; suite: 210; monrovia, CA 91106 ; 8002927902
• MDR Report Key: 20908746
• Report Number: 2023826-2024-05655
• Device Sequence Number: 7824173
• Product Code: QCB
• UDI-Device Identifier: 00840311311811
• UDI-Public: (01)00840311311811(11)240711(17)270630
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,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
• Device Model Number: VTICM5_ 13.2 (-13.50/ 1.50)
• Device Catalogue Number: VTICM5_ 13.2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2024
• Supplement Date Received by Manufacturer: 01/29/2025; 02/24/2025; 03/24/2025
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 01/29/2025; 02/27/2025; 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/11/2024
• 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; Hospitalization; Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female