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

Model Number VTICM5_12.1

Device Problem Optical Problem (3001)

Patient Problems Headache (1880); Visual Disturbances (2140); Halo (2227); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/13/2023

Event Type  Injury  

Event Description

The reporter indicated that the surgeon implanted a 12.1mm vticm5_12.1, -11.0/1.5/080 (sphere/cylinder/axis), implantable collamer lens, into the patient's left eye (os) on (b)(6) 2022.On (b)(6) 2023 the lens was explanted due to glare/halos, headache, and patient disstatisfaction.Problem resolved.

Manufacturer Narrative

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

Manufacturer Narrative

Corrected data: h6-health effect- clinical code: "4581- patient dissatisfaction" should be added.Claim# (b)(4).

• 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
• MDR Report Key: 17986875
• MDR Text Key: 326295043
• Report Number: 2023826-2023-04601
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date: 10/04/2023

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
• Device Operator: Health Professional
• Device Model Number: VTICM5_12.1
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2023
• Initial Date FDA Received: 10/23/2023
• Supplement Dates Manufacturer Received: 01/25/2024
• Supplement Dates FDA Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/16/2022
• 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: UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female