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

Model Number VTICMO12.6

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 07/30/2018

Event Type  Injury  

Manufacturer Narrative

Weight: unk.Ethnicity: unk.Race: unk.This product is manufactured in the u.S.But not marketed in the u.S.(b)(4).Work order search: no similar complaint was reported for units within the same lot.(b)(4).

Event Description

The reporter indicated the surgeon implanted a 12.6mm vticmo12.6 implantable collamer lens, -12.5/+1.5/036 (sphere/cylinder/axis), in the patients left eye (os), on (b)(6) 2018.The lens was explanted on (b)(6) 2018 due to the lens tore/broke during delivery into the eye.There was no patient injury.The lens was exchanged for another same model/length lens and the problem was resolved.The cause of the event was unknown.

Manufacturer Narrative

Device evaluation:lens returned in a microcentrifuge vial with moisture on the lens.Visual inspection found haptic torn.Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 9241885
• MDR Text Key: 163961646
• Report Number: 2023826-2019-01958
• 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: 09/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: VTICMO12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2019
• Initial Date Manufacturer Received: 09/28/2019
• Initial Date FDA Received: 10/25/2019
• Supplement Dates Manufacturer Received: 11/26/2019
• Supplement Dates FDA Received: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 18 YR