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

Model Number VICM5 12.6

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 01/16/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The reporter indicated that a 12.6mm vicm512.62, -11.00 diopter, implantable collamer lens tore during injection/delivery into the patient's left eye (os) on (b)(6) 2021.There was patient contact (lens touched the eye) with no patient injury.The lens was implanted, removed, and replaced intraoperatively on (b)(6) 2021.This resolved the problem.Cause of the event is reported as user error.

Manufacturer Narrative

H3: device evaluation is not required.Additional information: h6- work order search: no similar complaint type events were reported for units within the same lot.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: 11855246
• MDR Text Key: 252388774
• Report Number: 2023826-2021-01527
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: VICM5 12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/29/2021
• Initial Date FDA Received: 05/20/2021
• Supplement Dates Manufacturer Received: 12/15/2021
• Supplement Dates FDA Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/28/2020
• 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#1492564.; FOAMTIPPLUNGER MODEL#FTP,LOT#1493074.; INJECTOR MODEL#MSI-PF,LOT#UNK.
• Patient Age: 37 YR
• Patient Sex: Male