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

Model Number	VICM5_12.1 (-4.5)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Intraocular Pressure Increased (1937)
Date of Event	05/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: 4110 - work order search found no similar complaints.Manufacturer narrative:.Inflammation is identified in the labeling as a known potential adverse event following icl implantation.The dfu provides the surgeon instruction for complete ovd removal.Precaution: (6) after inserting this product, aspirate the viscoelastic substance completely from inside the eye.Do not use highly viscous viscoelastic substances that are difficult to aspirate completely.Claim# (b)(4).
Event or Problem Description
A facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced inflammation and elevated iop.Reportedly, "persistence ac reaction." medication as provided.
Additional Manufacturer Narrative
B5: persistent postoperative inflammation was observed.No diagnostic cultures or treatment were performed.Cause of the event is unknown.Reportedly, "persistent anterior chamber reaction despite on topical corticosteroid since surgery day.Otherwise, unaided vison remains good.No eye redness or discomfort.He also developed secondary high iop, most likely due to steroid usage." claim# (b)(4).
Additional Manufacturer Narrative
B5: the lens was explanted.Claim# (b)(4).
Additional Manufacturer Narrative
3331 - device history record review indicates that the product has been manufactured within the established process parameters and that there is no indication that the manufacturing and/or processing of the device contributed to the complaint issue.Claim# (b)(4).
Additional Manufacturer Narrative
Correction: d4 vicm5_12.6.Claim# (b)(4).

• Brand Name: EVO/EVO+VISIAN IMPLANTABLE COLLAMER LENS
• Common Device Name: PHAKIC 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 ; 800 royal oaks dr. suite:210; monrovia
• MDR Report Key: 22163341
• Report Number: 2023826-2025-00801
• Device Sequence Number: 8841931
• Product Code: MTA
• UDI-Device Identifier: 00840311300167
• UDI-Public: (01)00840311300167(11)231031(17)260930
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/07/2025

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: 09/30/2026
• Device Model Number: VICM5_12.1 (-4.5)
• Device Catalogue Number: VICM5_12.1
• 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: 05/23/2025
• Supplement Date Received by Manufacturer: 06/05/2025; 08/18/2025; 10/02/2025; 10/07/2025
• Initial Report FDA Received Date: 06/07/2025
• Supplement Report FDA Received Date: 06/27/2025; 09/12/2025; 10/05/2025; 10/07/2025
• Date Device Manufactured: 10/31/2023
• 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: SFC-45 - LOT #UNK.; FOAM TIP PLUNGER - LOT# UNK.; INJECTOR MODEL: MSI-PF - LOT# UNK.; UNK.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 27 YR
• Patient Sex: Male