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

Model Number	VTICMO13.2
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that a 13.2mm vticmo13.2 implantable collamer lens of a -5.0/1.0/081 (sphere/cylinder/axis) was implanted into the left eye (os) of a patient with pre-existing progressive myopia on (b)(6) 2024.Excessive vault is observed.Cause of the event is unknown with the device not failing as intended.The lens remains implanted.
Additional Manufacturer Narrative
A4-a6:unk.Claim# (b)(4).
Additional Manufacturer Narrative
D4: (b)(4).D6: explant - (b)(6) 2024.H4: 11/02/2022.H3: lens was returned with moisture in a microcentrifuge vial.Residue/debris was on the product.Visual inspection found no visible damage to the lens.Dimensional inspection found lens to be within specifications.B5: lens was removed.Later, a shorter length lens was implanted and the problem was resolved.Claim (b)(4).
Additional Manufacturer Narrative
B5: excessive vault and iris atrophy were observed.Cause of the event is unknown.Claim# (b)(4).
Additional Manufacturer Narrative
H3: incorrect lens received for product evaluation.Lens not returned.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. suite:210; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 19094083
• Report Number: 2023826-2024-01695
• Device Sequence Number: 17999283
• Product Code: QCB
• UDI-Device Identifier: 00840311311088
• UDI-Public: (01)00840311311088(11)221102(17)251031(21)T1231440
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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): 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2025
• Device Model Number: VTICMO13.2
• 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: 03/28/2024
• Supplement Date Received by Manufacturer: 07/11/2024; 09/19/2024; 03/25/2025
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 09/18/2024; 09/19/2024; 04/08/2025
• Date Device Manufactured: 11/02/2022
• 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 LOT# UNK; INJECTOR MODEL: MSI-PF - LOT# UNK
• Patient Age: 34 YR
• Patient Sex: Male