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

Model Number	VTICM5 12.6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6- investigation type 4110: lens work order search-no similar complaints reported for units within the same lot.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).
Event or Problem Description
A facility representative reported that an implantable collamer lens was implanted into the patient's eye.The patient experienced lens rotation not associated to a low vault.The lens was exchanged for a same length lens and the problem resolved.The cause of the event was reported as unknown.
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 not associated to a low vault.The lens was later explanted.In a subsequent surgery, a new lens with the same parameters was implanted and the problem resolved.The cause of the event was reported as unknown.Claim # (b)(4).
Additional Manufacturer Narrative
Correction: d6(a) - should be "unk" in the initial mdr.Additional information: h6 - type of investigation 3331 - device history record (dhr) review: based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within established process parameters and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.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 avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 20314595
• Report Number: 2023826-2024-04491
• Device Sequence Number: 18144033
• Product Code: QCB
• UDI-Device Identifier: 00840311308712
• UDI-Public: (01)00840311308712(11)230709(17)260630
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 09/06/2024

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 Expiration Date: 06/30/2026
• Device Model Number: VTICM5 12.6
• Device Catalogue Number: N/A
• 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: 09/06/2024
• Supplement Date Received by Manufacturer: 12/26/2024; 01/08/2025
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 12/26/2024; 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/09/2023
• 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 MODEL-FTP, LOT#-UNK.; INJECTOR MODEL-MSI-PF, LOT#-UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 28 YR
• Patient Sex: Male