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

Model Number VTICMO12.1

Device Problem No Apparent Adverse Event (3189)

Patient Problems Visual Disturbances (2140); Halo (2227)

Event Date 11/29/2023

Event Type  malfunction  

Manufacturer Narrative

A4: unk.A5: unk.A6: unk.D6b: unk.H6 - work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).

Event Description

The reporter indicated the surgeon implanted a 12.1mm vticmo12.1 implantable collamer lens -16.50/+1.0/128 (sphere/cylinder/axis), into the patient`s right eye (od) on (b)(6) 2023.This was the replacement lens for mfr.Report # 2023826-2024-00988.The problem was not resolved and the patient continued to have persistent glare/halos.The lens remained implanted.The cause of the event was patient was intolerant to halos associated with the central port of evo icl.Additional information has been requested but none has been forthcoming.

• 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: 18894199
• MDR Text Key: 337545719
• Report Number: 2023826-2024-01086
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00840311318117
• UDI-Public: 00840311318117
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/07/2024

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
• Device Operator: Health Professional
• Device Model Number: VTICMO12.1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/28/2023
• 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
• Patient Age: 40 YR
• Patient Sex: Male