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

Model Number VICMO 12.6

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

Patient Problem Insufficient Information (4580)

Event Date 05/10/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The reporter indicated that the surgeon implanted a 12.6mm vicmo12.6, -07.00 diopter, implantable collamer lens into the patient's right eye (od) on (b)(6) 2020.The lens was replaced with a longer length lens due to low vault on (b)(6) 2021.This resolved the problem.Cause of the event is reported as patient related factor.

Manufacturer Narrative

B5: per new information received on 12-apr-2022: cause of the event is unknown.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: cynthia thai ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 12214361
• MDR Text Key: 263077326
• Report Number: 2023826-2021-02693
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N/A
• 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: 07/02/2021

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: 06/30/2023
• Device Model Number: VICMO 12.6
• 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: 07/02/2021
• Initial Date FDA Received: 07/22/2021
• Supplement Dates Manufacturer Received: 04/12/2022
• Supplement Dates FDA Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2020
• 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.; FOAMTIPPLUNGER MODEL#FTP,LOT#UNK.; INJECTOR MODEL#MSI-PF,LOT#UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR
• Patient Sex: Female