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

Model Number VICM5 12.6

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The reporter indicated that the surgeon implanted and removed a 12.6mm vicm5 12.6, -05.00 diopter, implantable collamer lens from the patient's left eye (os) on (b)(6) 2019.The lens tore during injection, 60% of lens remained in cartridge.There was patient contact (lens touched the eye) with no patient injury.On (b)(6) 2020, a same size lens was implanted.This resolved the problem.Cause of the event is reported as user error.Reportedly, "nurse did not fold and charge as recommended.

Manufacturer Narrative

H3- device evaluation: lens was returned in a vial in liquid.Visual inspection found no visible damage.Claim# (b)(4).

Manufacturer Narrative

Corrected data: the lens received for device evaluation was not the correct lens.The previous supplemental mdr is not applicable to this claim.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: 10401673
• MDR Text Key: 203153842
• Report Number: 2023826-2020-01702
• 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: 07/24/2020

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: 11/30/2022
• Device Model Number: VICM5 12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Initial Date Manufacturer Received: 07/24/2020
• Initial Date FDA Received: 08/13/2020
• Supplement Dates Manufacturer Received: 03/08/2021; 07/23/2021
• Supplement Dates FDA Received: 04/06/2021; 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL#SFC-45, LOT#UNK; FOAMTIPPLUNGER MODEL#FTP, LOT#UNK
• Patient Age: 25 YR