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

Model Number	VTICM5_12.6
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6 - work order search: no similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 12.6mm vticm5 12.6, -18.0/1.5/091 (sphere/cylinder/axis), implantable collamer lens into the patient's right eye (od) on (b)(6) 2024.Low vault was observed.Lens remains implanted.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
Additional information: information has been added to the form.Claim# (b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 12.6mm vticm5 12.6, -18.0/1.5/091 (sphere/cylinder/axis), implantable collamer lens into the patient's right eye (od) on (b)(6) 2024.The lens was replaced with a longer length lens due to low vault on (b)(6) 2024.This resolved the problem.Reportedly, eye is stable.
Additional Manufacturer Narrative
D6b: explant date: on (b)(6) 2024.H1: type of reportable event: malfunction corrected to serious in initial mdr.Claim#: (b)(4).
Additional Manufacturer Narrative
B5 - -18.0/1.5/091" corrected to -8.0/1.5/091 in intial mdr & supplemental mdr #1.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
• MDR Report Key: 18701824
• Report Number: 2023826-2024-00260
• Device Sequence Number: 6195025
• Product Code: QCB
• UDI-Device Identifier: 00840311308064
• UDI-Public: 00840311308064
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Followup
• Report Date (Section B): 04/10/2024

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_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: 01/21/2024
• Supplement Date Received by Manufacturer: 02/22/2024; 04/10/2024; 04/22/2024
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 02/22/2024; 04/10/2024; 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2023
• 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.; FOAMTIPPLUNGER MODEL#FTP, LOT#UNK.; INJECTOR MODEL#MSI-PF, LOT#UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female