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

Model Number MICL13.2

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Intraocular Pressure Increased (1937); Missing Value Reason (3192)

Event Date 08/15/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Lens was returned dry, in a specimen container.Visual inspection found a torn haptic and residue on the lens surface.(b)(4).

Event Description

The reporter indicated that the surgeon implanted a 13.2mm, micl13.2, -14.0 diopter, implantable collamer lens into the patients right eye (od) on (b)(6) 2018.The lens was exchanged on (b)(6) 2018 with a shorter length lens due to pupil block with elevated iop (intraocular pressure), too large lens with ac shallowing, high vaulting and narrowing of angle.This exchange resolved the problem.

Manufacturer Narrative

(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: 7875111
• MDR Text Key: 120235860
• Report Number: 2023826-2018-01395
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542103374
• UDI-Public: 00841542103374
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: MTA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/15/2018

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: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2018
• Initial Date FDA Received: 09/13/2018
• Supplement Dates Manufacturer Received: 10/29/2018
• Supplement Dates FDA Received: 10/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2017
• 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: 36 YR