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

Model Number VICMO 12.6

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Sensation in Eye (1869); Visual Disturbances (2140); Eye Pain (4467)

Event Date 05/09/2020

Event Type  Injury  

Manufacturer Narrative

This product is not marketed in the us.No similar complaint type events were reported for units within the same lot.(b)(4).

Event Description

The reporter indicated that a 12.6 mm, vicmo12.6, -6.50 diopter, implantable collamer lens was implanted into the patients left eye (os) on (b)(6) 2020.On (b)(6) 2020 the lens was explanted, it was reported that after lens implant the patient experience foreign body sensation, pain and double images and required removal.Lens expalnt resolved the problem.Patient related factor was reported to be the cause of this event.

Manufacturer Narrative

H3: device evaluation: the lens was returned dry in a microcentrifuge vial with residue on the lens.Visual inspection found foreign residue on the lens surface and no visible damage to the lens.Claim# (b)(4).

Manufacturer Narrative

D10 - injector model corrected to msi-pf in the initial mdr.H6 - work order search: one additional similar complaint type event within associated lots was found.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: 10590933
• MDR Text Key: 208716753
• Report Number: 2023826-2020-02256
• 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: 08/26/2020

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: 09/30/2022
• Device Model Number: VICMO 12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Initial Date Manufacturer Received: 08/26/2020
• Initial Date FDA Received: 09/26/2020
• Supplement Dates Manufacturer Received: 02/16/2021; 07/16/2021
• Supplement Dates FDA Received: 03/12/2021; 07/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL: SFC-45 W/FTP, LOT# UNK; INJECTOR MODEL: MSI-TF, LOT# UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR