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 Known Impact Or Consequence To Patient (2692)

Event Date 05/05/2020

Event Type  malfunction  

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 12.6mm, vicm5_12.6, -9.5 diopter, implantable collamer lens was implanted, removed and exchanged within the same surgery.The reporter stated "could not have expected eyesight.It is possible that lens had stain." it was reported that the replacement lens resolved the problem, " eyesight was improved as expected." additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

Additional information: b5 - later it was reported that the doctor took early action because he found the stain or scratch on the surface of the lens; and may have noticed when implanting into the patient's eye.The stain is not visible without magnification.Claim#: (b)(4).

Manufacturer Narrative

H3 - device evaluation: lens was returned in a micro-centrifuge vial, dry with residue on the lens.Visual inspection found the lens optic and haptic torn with residue on the lens, also the lens was scratched with a tear on optic.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: 10463784
• MDR Text Key: 204938899
• Report Number: 2023826-2020-01916
• 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: 07/30/2020

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: 09/30/2022
• Device Model Number: VICM5 12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Initial Date Manufacturer Received: 07/30/2020
• Initial Date FDA Received: 08/27/2020
• Supplement Dates Manufacturer Received: 09/29/2020; 01/18/2021
• Supplement Dates FDA Received: 10/13/2020; 01/18/2021
• 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-PF, LOT# UNK
• Patient Age: 18 YR