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

Model Number VICMO12.6

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2020

Event Type  malfunction  

Manufacturer Narrative

This product is not marketed in the us.Work order search: no similar complaint type events were reported for units within the same lot.Claim#: (b)(4).

Event Description

The reporter indicated that a 12.6mm, vicmo12.6, -10.5 diopter, implantable collamer lens was implanted into the patients left eye (os) on (b)(6) 2020 and removed within the same surgery due to lens tear/break during injection/delivery into the eye.No patient injury was reported.On (b)(6) 2020 a replacement lens was implanted and the problem resolved.User error was reported to be the cause of this event.

Manufacturer Narrative

Additional information: h3-device evaluation: lens returned in a microcentrifuge vial with moisture and residue on product.Visual inspection found haptic torn with residue on lens.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: 10484168
• MDR Text Key: 219369846
• Report Number: 2023826-2020-02004
• 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
• Report Date: 08/03/2020

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: 08/31/2022
• Device Model Number: VICMO12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Initial Date Manufacturer Received: 08/03/2020
• Initial Date FDA Received: 09/02/2020
• Supplement Dates Manufacturer Received: 11/12/2020
• Supplement Dates FDA Received: 12/16/2020
• 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-PF, LOT # UNK
• Patient Age: 20 YR