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

Model Number VTICMO13.2

Device Problems Device Operates Differently Than Expected (2913); Activation Failure (3270)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 07/28/2017

Event Type  malfunction  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.(b)(4).Conclusion code: off-label use [anterior endothelium chamber depth < 3.0mm (2.97mm)].(b)(4).

Event Description

The reporter indicated that as the surgeon implanted a 13.2mm vticmo13.2 implantable collamer lens, diopter -9.0/+3.0/x086 into the patient's right eye (od), the lens tore/broke.The surgeon then exchanged the lens for the same size, similar diopter lens.This occurred on (b)(6) 2017.The problem was resolved.Attempts to obtain additional information have been unsuccessful.

Manufacturer Narrative

Additional information: after the lens was implanted, the doctor discovered it was "flipped inside the eye." intraoperatively, the surgeon removed the lens and the lens broke during explant.An alternate lens was implanted.(b)(4).

Manufacturer Narrative

Patient post-op bcva was 20/20 on (b)(6) 2017.Device evaluation: product evaluation found lens returned in a micro centrifuge vial with moisture on lens.Visual inspection found a missing piece of haptic.Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS
• Type of Device: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: michelle andres ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 6850682
• MDR Text Key: 85268865
• Report Number: 2023826-2017-01406
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/09/2017

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/31/2020
• Device Model Number: VTICMO13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/09/2017
• Initial Date FDA Received: 09/07/2017
• Supplement Dates Manufacturer Received: 09/08/2017; 10/26/2017
• Supplement Dates FDA Received: 09/27/2017; 11/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR