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

Model Number VICM5_13.2

Device Problems Positioning Failure (1158); No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/06/2018

Event Type  malfunction  

Manufacturer Narrative

This product is not marketed in the us.Product evaluation found that the lens was returned dry in a micro-centrifuge vial.Visual inspection found the haptic torn, residue on lens, and torn piece missing.No similar complaint type events were reported for units within the same lot.(b)(4).

Event Description

The reporter indicated that the surgeon implanted a 13.2 mm vicm5_13.2, -9.50 diopter, implantable collamer lens in the patient's right eye (od) on (b)(6) 2018.During implantation, the foam tip caught the optic and haptic and; causing a tear to the lens.The lens was intraoperatively exchanged with another lens and the problem was resolved.The patient is okay.

Manufacturer Narrative

Corrected data: correct patient identifier is (b)(6).(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: 7539113
• MDR Text Key: 109109544
• Report Number: 2023826-2018-00761
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 04/24/2018

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: 01/31/2020
• Device Model Number: VICM5_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: 05/08/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/24/2018
• Initial Date FDA Received: 05/23/2018
• Supplement Dates Manufacturer Received: 07/27/2018
• Supplement Dates FDA Received: 07/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2017
• 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 Age: 22 YR