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 Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 12/26/2019

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 on (b)(6) 2019 a 12.6mm, vicm5_12.6, -13.00 diopter, implantable collamer lens was implanted into the patients left eye (os) and removed within the same surgery due to a lens tear/break during injection/delivery into the eye, no patient injury.On (b)(6) 2019 a replacement lens was implanted and it was reported that the problem was resolved.

Manufacturer Narrative

H3 - device evaluation: lens was returned in a micro-centrifuge vial, dry, with clear surgical residue on the lens.Visual inspection found the lens haptic torn and residue on the lens.Corrected data: b4 - (b)(6) 2020.B5 - the reporter indicated that on (b)(6) 2019 a 12.6mm vicm5_12.6; -13.00 diopter implantable collamer lens tore/broke during injection/delivery into the patient's left eye (os).There was no patient contact/injury.On (b)(6) 2019 a replacement lens of the same model/length was implanted and the problem resolved.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: 10147987
• MDR Text Key: 195950511
• Report Number: 2023826-2020-01247
• 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: 05/13/2020

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: 03/31/2022
• Device Model Number: VICM5 12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2020
• Initial Date Manufacturer Received: 05/13/2020
• Initial Date FDA Received: 06/12/2020
• Supplement Dates Manufacturer Received: 07/20/2020
• Supplement Dates FDA Received: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 31 YR