MAUDE Adverse Event Report: STAAR SURGICAL IMPLANTABLE COLLAMER LENS (ICL); PHAKIC TORIC INTRAOCULAR LENS

Model Number	VTICM5_13.7
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intraocular Pressure Increased (1937)
Date of Event	11/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced low vault without rotation and elevated iop.Lens remains implanted.Additional information was requested.No further information is available at this time.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
H6 - type of investigation - lens work order search: no similar complaint type events reported for units within the same lot.Manufacturer narrative - iop elevation from baseline is identified in the labeling as a known potential adverse event following icl implantation.(b)(4).
Additional Manufacturer Narrative
H3 - device evaluation: lens was returned in a syringe in liquid.Visual inspection found the haptic torn.Dimensional inspection found the lens to be within specifications.Manufacture narrative: secondary surgical intervention to remove/replace/reposition the lens and iop elevation from baseline are identified in the labeling as a known potential adverse event following icl implantation.B5 - a facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced low vault without rotation and elevated iop.Lens was explanted and the problem resolved.Cause was reported as unknown.D4 - is not applicable the correct model # is vticmo 13.7 (-14.50/4.0) serial # (b)(6).Expiration date: 31-jul-2027 primary (udi)# (b)(4).D6b: explanted date: (b)(6) 2025.Claim #(b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• 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: 20931503
• Report Number: 2023826-2024-05699
• Device Sequence Number: 20110662
• Product Code: QCB
• UDI-Device Identifier: 00840311316014
• UDI-Public: (01)00840311316014(11)240815(17)270731
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: VTICM5_13.7
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• 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: 11/20/2024
• Supplement Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2024
• 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 W/FTP, LOT# UNK.; INJECTOR MODEL: MSI-PF, LOT# UNK.
• Patient Age: 38 YR
• Patient Sex: Male