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)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: work order search: no similar complaints within associated lots were found.(b)(4).
Event or Problem Description
A facility representative reported that a implantable collamer lens (icl) was implanted into a patient's eye.The lens was later removed and a shorter length lens was implanted.Further inquiry has been requested.None have been forthcoming.If any additional information is received, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
B5: the lens was later exchanged for a shorter length lens and the problem was resolved.H6: work order search was performed but was not required.Claim# (b)(4).
Additional Manufacturer Narrative
B5: lens exchanged due to excessive vault.Per current guidelines, the initial mdr is not applicable as this is not a reportable event.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 ; 800 royal oaks dr. suite210; monrovia 91016
• MDR Report Key: 20413514
• Report Number: 2023826-2024-04626
• Device Sequence Number: 18218651
• Product Code: QCB
• UDI-Device Identifier: 00840311308910
• UDI-Public: (01)00840311308910(11)231021(17)260930
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/19/2024

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 Expiration Date: 09/30/2026
• Device Model Number: VTICM5_12.6
• 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: 09/19/2024
• Supplement Date Received by Manufacturer: 11/15/2024; 01/17/2025
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 12/11/2024; 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2023
• 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# 1761528.; FOAM TIP PLUNGER - LOT# 1748709.; INJECTOR MODEL: MSI-PF - LOT# UNK.; UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female