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

Model Number VICM5 12.1

Device Problem Optical Problem (3001)

Patient Problems Visual Disturbances (2140); Discomfort (2330)

Event Date 08/06/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The reporter indicated that the surgeon implanted a 12.1mm vicm5 12.1, -01.25 diopter, implantable collamer lens into the patient's right eye (od) on (b)(6) 2021.The lens was explanted due to patient discomfort and glare on (b)(6) 2022.This resolved the problem.

Manufacturer Narrative

Corrected data: h6-health effect- clinical code: "2330" should be added.B5- the reporter indicated that the surgeon implanted a 12.1mm vicm5_12.1implantable collamer lens of diopter -1.25 into the patient's right eye (od) on (b)(6) 2021.The patient experienced discomfort/ glare.On (b)(6) 2022 the lens was explanted and the problem was resolved.Reportedly "no.There is no plan to implant another lens." claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC 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: 17279016
• MDR Text Key: 318585143
• Report Number: 2023826-2023-02617
• Device Sequence Number: 1
• Product Code: MTA
• 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
• Type of Report: Initial,Followup
• Report Date: 06/20/2023

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 Expiration Date: 02/29/2024
• Device Model Number: VICM5 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: 07/03/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2023
• Initial Date FDA Received: 07/07/2023
• Supplement Dates Manufacturer Received: 09/18/2023
• Supplement Dates FDA Received: 09/18/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/21/2021
• 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 Outcome(s): Required Intervention
• Patient Age: 35 YR
• Patient Sex: Female