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

Model Number VTICM 13.2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Halo (2227); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2024

Event Type  Injury  

Manufacturer Narrative

A4-a6: unk.H6 - type of investigation: 4110 - lens work order search: no similar complaint type events reported for units within the same lot.Claim #(b)(4).

Event Description

The reporter indicated that the surgeon implanted a 13.2mm vticm5_13.2 implantable collamer lens of diopter -11.5/1.5/164 (sphere/cylinder/axis) into the patient's left eye (os) on (b)(6) 2024.On (b)(6) 2024 the lens was explanted due to excessive vault, significant reduction of iridocorneal angles, and glare/haloes.On (b)(6) 2024 a replacement lens of a different model/ shorter length was implanted.Reportedly, "vault height satisfactory after icl exchange." the problem was resolved.The cause of the event was reported as other due to 'vault height too high.Icl oversized.'.

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: 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 ; 6263037902
• MDR Report Key: 19047640
• MDR Text Key: 339431980
• Report Number: 2023826-2024-01564
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00840311311491
• UDI-Public: 00840311311491
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/15/2024

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
• Device Operator: Health Professional
• Device Model Number: VTICM 13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/21/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL: SFC-45 - LOT# UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR
• Patient Sex: Male