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

Model Number	VTICMO12.6
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that the surgeon implanted a 12.6mm vticmo12.6; -16.50/+2.5/074 (sphere/cylinder/axis) implantable collamer lens into the patient's left eye (os) on (b)(6)2024.The patient experienced lens rotation and blurred vision.Lens was repositioned on (b)(6) 2024.It was reported that the surgeon plans on exchanging the lens in the future.Lens remains implanted.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
H6 - type of investigation: 4110 - lens work order search: no similar complaint type events reported for units within the same lot.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 and blurred vision.Lens was repositioned, and later exchanged with a longer length lens and the problem resolved.Glares at night was reported one month post exchange.H3 - device evaluation: the lens was returned dry in a microcentrifuge vial with residue/debris on the product.Visual inspection found no visible damage to the lens.Dimensional inspection found the lens to be within specifications.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 and blurred vision.Lens was repositioned.It was later explanted, and subsequent new lens of longer length was implanted and the problem.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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker ave; monrovia, CA 91016
• MDR Report Key: 18672807
• Report Number: 2023826-2024-00613
• Device Sequence Number: 12566936
• Product Code: QCB
• UDI-Device Identifier: 00840311323517
• UDI-Public: 00840311323517
• 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: 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,Followup
• Report Date (Section B): 01/23/2024

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
• 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: 01/23/2024
• Supplement Date Received by Manufacturer: 01/03/2025; 02/07/2025
• Initial Report FDA Received Date: 02/08/2024
• Supplement Report FDA Received Date: 02/03/2025; 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2023
• 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: INJECTOR MODEL-MSI-PF, LOT#-UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female