MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS; PHAKIC TORIC INTRAOCULAR LENS

Model Number VTICM5_12.6

Device Problems Off-Label Use (1494); No Apparent Adverse Event (3189)

Patient Problem No Patient Involvement (2645)

Event Date 12/18/2019

Event Type  malfunction  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.(b)(4).No similar complaint type events reported for units within the same lot.(b)(4).

Event Description

The reporter indicated that, while attempting to implant a 12.6mm vticm5_12.6 implantable collamer lens, -13.5/+2.5/090 (sphere/cylinder/axis) into the patient's right eye (od), it was torn.This occurred on (b)(6) 2019.There was no patient contact with the lens.On (b)(6) 2019 an alternate lens was successfully implanted and the problem is resolved.

Manufacturer Narrative

Additional information: h3-device evaluation: lens returned in a micro-centrifuge vial with moisture on lens and clear surgical residue on product.Visual inspection found haptic torn and residue on lens.Claim # (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS
• Type of Device: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia, ca
• MDR Report Key: 9910965
• MDR Text Key: 190987135
• Report Number: 2023826-2020-00680
• Device Sequence Number: 1
• Product Code: QCB
• 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: 03/06/2020

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: VTICM5_12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2020
• Initial Date Manufacturer Received: 03/06/2020
• Initial Date FDA Received: 04/01/2020
• Supplement Dates Manufacturer Received: 05/26/2020
• Supplement Dates FDA Received: 06/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 34 YR