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

Model Number VICMO12.6

Device Problem Inadequacy of Device Shape and/or Size (1583)

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

Event Date 10/02/2021

Event Type  Injury  

Event Description

The reporter indicated that a 12.6mm vicmo 12.6 implantable collamer lens of -5.5 diopter into the patients left eye (os) on (b)(6) 2021.On (b)(6) 2021 the lens was exchanged for a shorter length lens due to excessive vault.The exchange resolved the problem.Cause is reported as unknown.

Manufacturer Narrative

This product is not marketed in the us.(b)(4).

Manufacturer Narrative

B5-the reporter indicated that a 12.6mm vicmo 12.6 implantable collamer lens of -5.5 diopter into the patients left eye (os) on (b)(6) 2021.On (b)(6) 2021 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 is reported as unknown.Clinical code- 4581-significant reduction of irido-corneal angles.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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 13122991
• MDR Text Key: 284825025
• Report Number: 2023826-2021-04777
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• 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: 12/03/2021

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: 05/31/2024
• Device Model Number: VICMO12.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 03/23/2022
• Supplement Dates FDA Received: 03/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2021
• 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
• Treatment: CARTRIDGE MODEL: SFC-45: LOT# UNK.; FOAM TIP PLUNGER (FTP), LOT# UNK.; INJECTOR MODEL: MSI-PF, LOT# UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR
• Patient Sex: Female