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

Model Number	VTICM5_13.7
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Optical Problem (3001)
Health Effect - Clinical Codes	Halo (2227); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that a 13.7mm vticm5_13.7 -12.00/2.0/071 (sphere/cylinder/axis) implantable collamer lens was implanted into the patients right eye (od) on (b)(6) 2023.On (b)(6) 2023 the lens was explanted due to excessive vault.Cause of event was unknown.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Corrected data: h6- health effect- clinical code: "4581- significant reduction of iridocorneal angles" should be added.Additional data: b5- the reporter indicated that the surgeon implanted a 13.7mm vticmo 13.7 implantable collamer lens of diopter -12.0/+2.0/71 (sphere/cylinder/axis) into the patient's right eye (od) on (b)(6) 2023.The patient experienced an excessive vault and significant reduction of irido-corneal angles.On (b)(6) 2023 the lens was explanted.Reportedly "the new lens was never installed again and was therefore returned.Client canceled the treatment.He had no confidence that the new lens would be any good." the reporter indicated the cause of the event was the device- "wrong wtw".Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: h6-health effect- clinical code: "2227" should be added.H6- medical device problem code:"3001" should be added.B5- the patient also experienced glare/halos.Claim# (b)(4).
Additional Manufacturer Narrative
Device evaluation: h3 - type of investigation code: 10- device evaluation: the lens was returned in a microcentrifuge vial with liquid.Visual inspection found no visible damage.Dimensional inspection found the lens to be within specifications.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 enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 16519714
• Report Number: 2023826-2023-00810
• Device Sequence Number: 16742504
• Product Code: QCB
• UDI-Device Identifier: 00840311315147
• UDI-Public: 00840311315147
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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,Followup
• Report Date (Section B): 02/09/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2025
• Device Model Number: VTICM5_13.7
• 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: 02/09/2023
• Supplement Date Received by Manufacturer: 11/07/2023; 12/20/2023; 03/26/2025
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 12/13/2023; 12/20/2023; 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2022
• 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: INJECTOR MODEL: MSI-PF, LOT# UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 33 YR
• Patient Sex: Male