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

Model Number	VTICMO13.2
Medical Device Problem Codes	Off-Label Use (1494); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm vticmo13.2, -15.5/3.5/074 (sphere/cylinder/axis), implantable collamer lens into the patient's right eye (od) on (b)(6) 2023.Excessive vault was observed.Pressure controlled with oral and topical medications.Lens remains implanted.
Additional Manufacturer Narrative
A4 - unk.A5 - unk.A6 - unk.H6 - work order search: no similar complaint type events were reported for units within the same lot.Claim#: (b)(4).
Additional Manufacturer Narrative
Additional information: b5: the reporter indicated that the surgeon implanted a 13.2mm vticmo13.2, -15.5/3.5/074 (sphere/cylinder/axis), implantable collamer lens into the patient's right eye (od) on (b)(6) 2023.Excessive vault was observed.Pressure controlled with oral and topical medications.The lens was explanted on (b)(6) 2023.In a separate surgery on the same date the lens was replaced with a shorter length lens.This resolved the problem.Claim# (b)(4).
Additional Manufacturer Narrative
D9: return date: 19-sep-2023.H6: 1494: should be added for correction- off-label acd<3.00mm at the time of 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 SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 17039563
• Report Number: 2023826-2023-01881
• Device Sequence Number: 20461864
• Product Code: QCB
• UDI-Device Identifier: 00840311328536
• UDI-Public: 00840311328536
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 05/09/2023

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: 12/31/2025
• Device Model Number: VTICMO13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• 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: 05/09/2023
• Supplement Date Received by Manufacturer: 06/13/2023; 10/05/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 07/11/2023; 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2023
• 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 Sex: Female