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

Model Number	VTICM5 12.6
Medical Device Problem Codes	Misfocusing (1401); Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923); Optical Problem (3001)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Blurred Vision (2137); Visual Disturbances (2140); Discomfort (2330); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that an implantable collamer lens of unknown model and size was implanted.Doctor requested consultation for patient with icl rotation and pigment dispersion.The lens remains implanted.No further information has been provided.Attempts to obtain additional information have not been successful.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
4581-pigment dispersion claim#: (b)(4).
Additional Manufacturer Narrative
Corrected data: b5-the reporter indicated that a 12.6mm vticm5 12.6 implantable collamer lens of -9.00/1.0/154 (sphere/cylinder/axis) was implanted into the patients right eye (od) on (b)(6)2023.Excessive vault; lens rotation; pigment dispersion; blurred vision and unreactive (fixed) pupil was reported.On 02-oct-2023 the lens was repositioned and this did not resolve the problem.Anterior chamber irrigation/evacuation of visco/fluids was performed.Patient is on ophthalmic medications.(b)(6)-pigment dispersion; unreactive(fixed) pipil.Claim# (b)(4).
Event or Problem Description
The reporter indicated that a 12.6mm vticm5 12.6 implantable collamer lens of -9.00/1.0/154 (sphere/cylinder/axis) was implanted into the patients right eye (od) on (b)(6) 2023.Excessive vault; lens rotation; pigment dispersion; blurred vision and unreactive (fixed) pupil was reported.On (b)(6) 2023 the lens was repositioned and this did not resolve the problem.Anterior chamber irrigation/evacuation of visco/fluids was performed.Patient is on ophthalmic medications.

• 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: 18060314
• Report Number: 2023826-2023-04944
• Device Sequence Number: 12695034
• Product Code: QCB
• UDI-Device Identifier: 00840311307807
• UDI-Public: 00840311307807
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2023
• 2 Devices were Involved in the Event: 1 2

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: 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: 10/20/2023
• Supplement Date Received by Manufacturer: 01/25/2024
• Initial Report FDA Received Date: 11/02/2023
• Supplement Report FDA Received Date: 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2023
• 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 (FTP), LOT# UNK; INJECTOR MODEL: MSI-PF, LOT# UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female