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

Model Number VTICM5_12.6

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/16/2020

Event Type  malfunction  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.The lens was returned in a micro-centrifuge vial, with moisture on lens.Visual inspection found no visible damage to the lens.

Event Description

The reporter indicated the surgeon inserted and removed a 12.6mm vticm5_12.6 implantable collamer lens, -10.00/+1.0/102 (sphere/cylinder/axis), during the same surgery due to excessive vaulting.The lens was exchanged for a shorter lens during the same surgery and the problem was resolved.The patient is happy.The cause of the event was unknown.

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia, ca
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia, ca
• Manufacturer Contact: cynthia thai ; 1911 walker avenue; monrovia, ca ; 3037902237
• MDR Report Key: 10440595
• MDR Text Key: 204020255
• Report Number: 2023826-2020-01808
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/29/2020

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: 07/31/2022
• Device Model Number: VTICM5_12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/29/2020
• Initial Date FDA Received: 08/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2019
• 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 Age: 26 YR