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

Model Number MICL13.2

Device Problems No Apparent Adverse Event (3189); Ejection Problem (4009)

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

Event Date 01/22/2020

Event Type  malfunction  

Manufacturer Narrative

The lens was returned dry in lens vial, wlith residue on lens.Visual inspection found the lens optic and haptic torn.No similar complaint was reported for units within the same lot.(b)(4).

Event Description

The reporter indicated while the surgeon was inserting a 13.2mm micl13.2 implantable collamer lens, - 8.0 diopter, the foam tip plunger overrode the lens and while trying to disengage, the lens was ripped.There was patient contact.The backup lens was implanted.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia, ca
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia, ca
• Manufacturer Contact: cynthia thai ; 1911 walker avenue; monrovia, ca ; 3037902237
• MDR Report Key: 9747629
• MDR Text Key: 190644393
• Report Number: 2023826-2020-00318
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542103251
• UDI-Public: 00841542103251
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/03/2020

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: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2020
• Initial Date FDA Received: 02/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2019
• 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