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

Model Number	VTICM5 13.2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter indicated that a 13.2 vticm5 13.2 implantable collamer lens of -5.5/1.00/111 (sphere/cylinder/axis) was implanted into the patient's right eye (od) on (b)(6) 2024.On (b)(6) 2024 the lens was exchanged for a shorter length lens due to excessive vault and significant reduction of irido-corneal angles.The exchange resolved the problem.Cause reported as other.
Additional Manufacturer Narrative
Additional data: h3 - device evaluation: the lens was returned in a microcentrifuge vial with moisture and residue/debris on the product.Visual inspection found fibre and no visible damage to the lens.Dimensional inspection found the lens to be within specifications.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data; b5: the reporter indicated that a 13.2 vticm5 13.2 implantable collamer lens of -5.5/1.00/111 (sphere/cylinder/axis) was implanted into the patient's right eye (od) on (b)(6) 2024.On (b)(6) 2024 the lens was exchanged for a shorter length lens due to excessive vault and significant reduction of irido-corneal angles.The exchange resolved the problem.Cause reported as other.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 ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 19705483
• Report Number: 2023826-2024-02995
• Device Sequence Number: 3690145
• Product Code: QCB
• UDI-Device Identifier: 00840311311095
• UDI-Public: 00840311311095
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Report Date (Section B): 06/10/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: VTICM5 13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2024
• Supplement Date Received by Manufacturer: 08/20/2024; 09/23/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 09/09/2024; 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female