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

Model Number VICMO 12.6

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/18/2020

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 the surgeon implanted and removed a 12.6mm vicmo12.6, -11.00 diopter, implantable collamer lens into the patient's left eye (os) on (b)(6) 2020.The lens tore during injection.There was patient contact (lens touched the eye) with no patient injury.A lens was implanted on (b)(6) 2020, this resolved the problem.Cause of the event is reported as unknown.

Manufacturer Narrative

H3 - device evaluation: lens was returned in a micro-centrifuge vial with moisture on the lens.Visual inspection found the lens optic and haptic torn.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: 10401661
• MDR Text Key: 203153889
• Report Number: 2023826-2020-01695
• 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
• Report Date: 07/22/2020

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: 12/31/2022
• Device Model Number: VICMO 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: 08/12/2020
• Initial Date Manufacturer Received: 07/22/2020
• Initial Date FDA Received: 08/13/2020
• Supplement Dates Manufacturer Received: 10/13/2020
• Supplement Dates FDA Received: 10/15/2020
• 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; INJECTOR MODEL#MSI-PF, LOT#UNK
• Patient Age: 25 YR