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

Model Number VICMO12.6

Device Problems Defective Device (2588); Unintended Movement (3026)

Patient Problems Pain (1994); Blurred Vision (2137); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/12/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The reporter indicated the surgeon implanted a 12.6mm vicmo12.6 implantable collamer lens, -09.50 diopter, in the patients left eye (os), on (b)(6) 2021.The patient was reported with hyperopia and astigmatism, which caused bad and blurred vision.Also reported permanenet loss of bcva.The lens was also reported as having flipped.The patient had a small eye, there was pupilar constriction and the pupil began to close during the surgery.The lens was explanted and re-implanted on (b)(6) 2021.Peribulbar block was administered during the 1st surgery (initial) and 2nd surgery (re-implant).The problem was resolved.The cause of the event was unknown.Two hours after the re-implant surgery, anterior chamber a little bit narrow and pupil dilated.The patient is happy with the results of the surgery.

Manufacturer Narrative

Additional information: b5 - it was also indicated that the patient experienced pain.Reporter indicated there was product nonconformity but this was not specified on.Lens was implanted upside down/flipped.It was later clarified that the lens was explanted on (b)(6) 2021, and the next day re-implanted.H6 - 4581 - loss of bcva.Claim# (b)(4).

Manufacturer Narrative

Additional information: b5/h10- it was later clarified that the lens was removed on (b)(6) 2021 and properly reimplanted, intraoperatively and not in a separate surgery.This had resolved the problem.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: 11557439
• MDR Text Key: 242040503
• Report Number: 2023826-2021-00740
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: VICMO12.6
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL SFC-45 - LOT # 1501764; FOAM TIP PLUNGER MODEL FTP - LOT # 1485608; INJECTOR MODEL MSI-PF - LOT # UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR