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

Model Number	VTICM5_ 13.2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: b5- the reporter indicated that the surgeon implanted a 13.2mm vticm5_ 13.2 implantable collamer lens of diopter -10.00/3.5/025 (sphere/cylinder/axis) into the patient's left eye (os) on (b)(6) 2023.The patient experienced a lens rotation not associated with a low vault, refractive change over time, permanent loss of bcva.Reportedly "lens rotation, at several times." the lens remains implanted.The reporter indicated the cause of the event is unknown.Claim# (b)(4).
Additional Manufacturer Narrative
Addiitonal information: b5- on (b)(6) 2024 the lens was exchanged with a different model, longer length lens and the problem was resolved.H6- health effect- impact code (f): "2199" should be removed and "4629" should be added.Claim# (b)(4).
Additional Manufacturer Narrative
H6- investigation type code: 4110- lens work order search-no similar complaint event(s) within associated lots were found.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm vticm5_ 13.2 implantable collamer lens of diopter -10.00/3.5/025 (sphere/cylinder/axis) into the patient's left eye (os) on (b)(6) 2023.The patient experienced a lens rotation not associated with a low vault.Reportedly "lens rotation, at several times." the lens remains implanted.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Device evaluation: h3 - type of investigation code: 10- device evaluation: the lens was returned in a microcentrifuge vial with liquid and residue/debris on product.Visual inspection found no visible damage.Dimensional inspection found the lens to be within specifications.Corrected data: b5- on 22/aug/2024 the lens was exchanged with a longer length, same model and power lens and the problem was resolved.H11- 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).

• 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 avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 19570692
• Report Number: 2023826-2024-02764
• Device Sequence Number: 12501218
• Product Code: QCB
• UDI-Device Identifier: 00840311312580
• UDI-Public: 00840311312580
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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,Followup
• Report Date (Section B): 06/14/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Model Number: VTICM5_ 13.2
• 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: 06/14/2024
• Supplement Date Received by Manufacturer: 06/25/2024; 08/22/2024; 10/25/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 06/25/2024; 10/01/2024; 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2023
• 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# 1642375; FOAM TIP PLUNGER (FTP), LOT# 1646588; MSI-PF, LOT# UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male