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

Model Number VICM5_13.2

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/04/2021

Event Type  malfunction  

Event Description

The reporter indicated the surgeon implanted a 13.2mm vicm5_13.2 implantable collamer lens, diopter -8.0 into the patient's right eye (od) on (b)(6) 2021.The surgeon reports low vault.Reportedly, the surgeon has decided to leave the lens implanted.

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.No similar complaints reported for units within the same lot.Claim # (b)(4).

Manufacturer Narrative

B5-updated information: reportedly the doctor decided to exchange the lens because the vault was reduced since the last visit.Claim# (b)(4).

Manufacturer Narrative

B5-corrected information: reportedly the lens remains implanted; the patient does not want any further surgery.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 ; 8002927902
• MDR Report Key: 13122741
• MDR Text Key: 285005269
• Report Number: 2023826-2021-05000
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: VICM5_13.2
• 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: 12/04/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 01/24/2022; 03/08/2022
• Supplement Dates FDA Received: 03/03/2022; 04/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2021
• 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 MODEL-FTP, LOT#-UNK; INJECTOR MODEL-MSI-PF, LOT#-UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Sex: Male