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

Model Number	VTICMO12.6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
A health care professional reported that an implantable collamer lens was implanted into the patients eye.The patient experienced low vaulting and double vision.The surgeon is planning to exchange the lens.To the best of our knowledge the lens remains implanted.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
H11 manufacturer narrative - double vision, is identified in the labeling as a known potential adverse event following icl implantation.Claim# (b)(4).
Additional Manufacturer Narrative
H6 - work order search: no additional similar complaint type events within associated lots were found.Claim # (b)(4).
Additional Manufacturer Narrative
B3.Date of event (dd-mmm-yyyy): 20-dec-2024.Claim # (b)(4).
Additional Manufacturer Narrative
Upon further review, it has been determined that the event is not mdr reportable.There has been no report of serious injury or malfunction.Initial mdr is not applicable.
Additional Manufacturer Narrative
B5 - a healthcare professional reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced low vault with rotation and pigment dispersion.Due to low vault with rotation and pigment dispersion, the lens was exchanged for a longer length lens.This resolved the problem.The cause of the event was reported as unknown.Claim # (b)(4).
Additional Manufacturer Narrative
H3 - device evaluation: the lens was returned dry in a microcentrifuge with debris/residue on the lens.Visual inspection found the lens haptic torn, with foreign material on the lens surface, specifically debris throughout the lens.Dimensional inspection found the lens to be within specifications.Claim # (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• 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 ; 1911 walker ave; monrovia, CA 91016
• MDR Report Key: 21146821
• Report Number: 2023826-2025-00095
• Device Sequence Number: 21164773
• Product Code: QCB
• UDI-Device Identifier: 00840311323111
• UDI-Public: (01)00840311323111(11)240804(17)270731
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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,Followup
• Report Date (Section B): 12/19/2024

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
• Operator of Device: Health Professional
• Device Model Number: VTICMO12.6
• 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: 12/19/2024
• Supplement Date Received by Manufacturer: 03/13/2025; 03/26/2025; 05/05/2025; 02/04/2025; 07/10/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 03/18/2025; 03/26/2025; 05/06/2025; 06/25/2025; 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2024
• 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; Required Intervention
• Patient Sex: Female