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

Model Number	VTICM5 12.6 (-11.0/+2.0)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	01/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare professional reported that an implantable collamer lens was implanted into the patient's eye.The surgeon reports the lens rotated, then was repositioned that same day of postop, but the lens rotated back later and induced hyperopia and astigmatism.Lens remains implanted.
Additional Manufacturer Narrative
Manufacturer narrative: 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).
Additional Manufacturer Narrative
B5 - a facility representative reported that an implantable collamer lens was implanted into the patient's eye.The patient experienced lens rotation.The lens was repositioned the same day postop but it has rotated back, now inducing hyperopia and astigmatism (refractive surprise).The lens was exchanged with a longer length lens.The cause of the event was reported as unknown.H3 - device evaluation is required but has not yet been performed.H6 - type of investigation: 4110 - lens work order search: no similar complaint type events reported for units within the same lot.Manufacturer narrative: refractive surprise: 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.Claim#: (b)(4).
Additional Manufacturer Narrative
H3 - device evaluation: lens was returned in a micro-centrifuge vial, in liquid with residue/debris on the product.Visual inspection found no visible damage to the lens.Dimensional inspection found the lens within specifications.Functional inspection found the returned lens did not meet original values measured at the time of manufacturing.Claim#: (b)(4).
Additional Manufacturer Narrative
Additional information: h6 - type of investigation 3331 - device history record (dhr) review: based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within established process parameters and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 21380149
• Report Number: 2023826-2025-00254
• Device Sequence Number: 20906055
• Product Code: QCB
• UDI-Device Identifier: 00840311308408
• UDI-Public: (01)00840311308408(11)240416(17)270331
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/24/2025

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 (-11.0/+2.0)
• Device Catalogue Number: VTICM5 12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2025
• Supplement Date Received by Manufacturer: 06/03/2025; 06/27/2025; 09/04/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 06/03/2025; 06/30/2025; 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR
• Patient Sex: Female