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

Model Number VICMO12.6

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

Patient Problem Cataract (1766)

Event Date 07/31/2020

Event Type  Injury  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.(b)(4).

Event Description

The reporter indicated the surgeon implanted a 12.6mm vicmo12.6 implantable collamer lens, diopter -9.5 into the patient's right eye (od) on (b)(6) 2020.Intraoperatively the lens was explanted due to lens opacity asc and the problem was resolved.The cause of the event is reported as user error.Reportedly, the tip of the knife touched the anterior lens capsule.

Manufacturer Narrative

Additional information; h3-device evaluation: lens returned in a microcentrifuge vial with moisture.Visual inspection found no visible damage to lens.Claim# (b)(4).

Manufacturer Narrative

The reporter indicated the surgeon implanted a 12.6mm vicmo12.6 implantable collamer lens, diopter -9.5 into the patient's right eye (od) on (b)(6) 2020.The lens was removed intra-operatively within initial surgery; due to lens opacity asc.Phacoemulsification & iol implantation also reported.The reporter states the problem was resolved.H6 - health impact code 4625-additional surgery (phacoemulsification & iol implantation).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
• MDR Report Key: 10687738
• MDR Text Key: 211624350
• Report Number: 2023826-2020-02387
• 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,Followup
• Report Date: 09/20/2020

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: 11/30/2022
• Device Model Number: VICMO12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Initial Date Manufacturer Received: 09/20/2020
• Initial Date FDA Received: 10/15/2020
• Supplement Dates Manufacturer Received: 02/19/2021; 07/01/2021
• Supplement Dates FDA Received: 04/06/2021; 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL-SFC-45, LOT#-UNK; FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK; INJECTOR MODEL-MSI-PF, LOT#-UNK; CARTRIDGE MODEL-SFC-45, LOT#-UNK; FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK; INJECTOR MODEL-MSI-PF, LOT#-UNK
• Patient Outcome(s): Other
• Patient Age: 26 YR