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

Model Number VICMO12.1

Device Problems Off-Label Use (1494); Inadequacy of Device Shape and/or Size (1583); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 01/10/2020

Event Type  malfunction  

Manufacturer Narrative

The product is manufactured in the us, but not marketed in the us.(b)(4).

Event Description

The reporter indicated the surgeon implanted a 12.1mm vicmo12.1 implantable collamer lens, diopter -7.5 into the patient's left eye (os) on (b)(6) 2020.Within the same surgery the lens was exchanged with a longer lens due to low vault.The problem was resolved.The cause of the event is reported as user error.

Manufacturer Narrative

Additional information: h3: device evaluation: lens was returned in a micro centrifuge vial with moisture on the lens.Visual inspection found the optic and haptic torn.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
• MDR Report Key: 10335338
• MDR Text Key: 202040587
• Report Number: 2023826-2020-01540
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 06/29/2020

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: 09/30/2022
• Device Model Number: VICMO12.1
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Initial Date Manufacturer Received: 06/29/2020
• Initial Date FDA Received: 07/28/2020
• Supplement Dates Manufacturer Received: 11/11/2020
• Supplement Dates FDA Received: 12/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INJECTOR MODEL-MSI-PF, LOT#-UNK
• Patient Age: 22 YR