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

Model Number VTICM5_13.2

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2018

Event Type  malfunction  

Manufacturer Narrative

This product is not marketed in the us.(b)(4).

Event Description

The reporter indicated that the surgeon implanted a 13.2 mm vticm5_13.2, -8.5/3.0/89 (sphere/cylinder/axis), implantable collamer lens into the patient's right eye (od) on (b)(6) 2018.The lens was implanted upside-down and was explanted in the same surgery.The lens was damaged during explantation.There was no patient injury.A replacement lens was implanted a week later and it is all fine.It is reported that the cause of the event was due to user error.

Manufacturer Narrative

Device evaluation: the lens was returned dry in a lens vial with residue on the product.Visual inspection found the lens torn with presence of residue on the lens surface.The lens was missing the torn piece.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 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: cynthia thai ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 7481807
• MDR Text Key: 107196324
• Report Number: 2023826-2018-00625
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 04/03/2018

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: Physician
• Device Expiration Date: 12/31/2020
• Device Model Number: VTICM5_13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/03/2018
• Initial Date FDA Received: 05/02/2018
• Supplement Dates Manufacturer Received: 05/30/2018
• Supplement Dates FDA Received: 06/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2018
• 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 Age: 28 YR