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

Model Number	VTICM5_12.6 (-5.50/2.0)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Over/under correction and secondary surgical intervention to remove/replace/reposition is identified in the labeling as a known potential adverse event following icl implantation.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.H3: device evaluation is required but has not yet been performed.H6: investigation type 4110: lens work order search - no similar complaint event(s) within associated lots were found.H6: health effect - clinical code (e): 4581 - under refraction.Claim: (b)(4).
Event or Problem Description
A facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced under refraction.The lens was exchanged with a same length lens, but different power and the problem resolved.It has been noted that the surgeon selected a different lens size than that initially suggested by the icl calculation software.Therefore, there is not enough safety and effectiveness data to support implantation in this patient category.
Additional Manufacturer Narrative
Correction: over/under correction and secondary surgical intervention to remove/replace/reposition is identified in the labeling as a known potential adverse event following icl implantation.H3: device evaluation is not required.H6: investigation type 4110: lens work order search - no similar complaint event(s) within associated lots were found.H6: health effect - clinical code (e): 4581 - under refraction.Claim: (b)(4).

• Brand Name: EVO/EVO+VISIAN IMPLANTABLE COLLAMER LENS
• Common Device Name: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 22208430
• Report Number: 2023826-2025-00757
• Device Sequence Number: 12673686
• Product Code: QCB
• UDI-Device Identifier: 00840311308293
• UDI-Public: (01)00840311308293(11)230807(17)260731
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 06/14/2025

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 Expiration Date: 07/31/2026
• Device Model Number: VTICM5_12.6 (-5.50/2.0)
• Device Catalogue Number: VTICM5_12.6
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 06/14/2025
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2023
• 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: UNKNOWN, LOT#: UNKNOWN; FOAM TIP PLUNGER: UNKNOWN, LOT#: UNKNOWN; INJECTOR MODEL: UNKNOWN , LOT#: UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Unknown