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

Model Number VTICM5_12.1

Device Problems Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 07/25/2017

Event Type  Injury  

Manufacturer Narrative

This product is manufactured but not marketed in the u.S.Device evaluation: lens was returned in liquid in the lens case/vial.Visual inspection found the haptic broken.(b)(4).Work order search: no similar complaint types reported for units within the same lot.Conclusion code: off-label use [anterior endothelium chamber depth < 3.0mm (2.97mm)].(b)(4).

Event Description

The reporter indicated that the surgeon implanted a 12.1mm vticm5_12.1, diopter -8.50/2.5/90 implantable collamer lens into the patient's left eye (os) on (b)(6) 2017.Reportedly, the lens was implanted "inside out." complaint form states that as the lens was removed, it was discovered to have a "crack" on the lens.It is unknown as to when or how the crack occurred on the lens.Explant date is not reported.According to claim reporter, the surgery has been postponed and alternate lens is ordered.

Manufacturer Narrative

The explant date is same as the implant date i.E.,(b)(6) 2017.(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 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: 6850675
• MDR Text Key: 85268532
• Report Number: 2023826-2017-01404
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• 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
• 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?: No
• Device Operator: Physician
• Device Expiration Date: 04/30/2020
• Device Model Number: VTICM5_12.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2017
• 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: 10/13/2017
• Supplement Dates FDA Received: 10/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2017
• 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: 21 YR