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

Model Number MICL13.7

Device Problems Entrapment of Device (1212); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/01/2017

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: product evaluation found that the lens was returned in liquid in a lens case/vial.Visual inspection found a piece of haptic missing.Work order search: no similar complaints types events were reported for units within the same lot.(b)(4).

Event Description

The reporter indicated that the surgeon attempted to implant a micl13.7,-10.0 diopter, implantable collamer lens in the patient's right eye (od) on (b)(6) 2017.The surgeon could not advance the lens in the injector.The surgeon believed that the lens could have been damaged and cause it to be stuck.There was no patient contact with the device.During the same surgery; a back-up lens was used and it was successful.

Manufacturer Narrative

Corrected data: date of birth corrected from (b)(6) to (b)(6).Type of reportable event corrected from serious injury to malfunction.Device evaluation: product evaluation found that the lens was returned in liquid in a lens case/vial.Visual inspection found the lens missing pieces of its haptic.(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: 7069171
• MDR Text Key: 93281301
• Report Number: 2023826-2017-01796
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542103565
• UDI-Public: 00841542103565
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/01/2017

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: 01/31/2019
• Device Model Number: MICL13.7
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/01/2017
• Initial Date FDA Received: 11/29/2017
• Supplement Dates Manufacturer Received: 01/26/2018
• Supplement Dates FDA Received: 01/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2017
• 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 Age: 25 YR