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

Model Number MICL12.6

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

Patient Problems Headache (1880); Intraocular Pressure Increased (1937); Nausea (1970); Pupillary Block (2026); Blurred Vision (2137); No Code Available (3191)

Event Date 10/13/2017

Event Type  Injury  

Manufacturer Narrative

Device evaluation: the lens was returned in liquid, in a vial.Visual inspection found pieces of lens haptic torn off and missing.(b)(4).

Event Description

The reporter indicated the surgeon implanted a 12.6mm micl12.6 implantable collamer lens, -16.0 diopter, in the patient's left eye (os) on (b)(6) 2017.The lens was explanted on (b)(6) 2017 due to excessive vaulting and elevated intraocular pressure (pupillary block).The patient experienced blurry vision, headache and nausea.The lens was exchanged for a shorter lens and the problem was resolved.The patient's post-op best-corrected visual acuity was 20/25 and iop was 18.

Manufacturer Narrative

Work order search: one similar complaint type event was reported for units within the same lot.(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 ; 6263037902
• MDR Report Key: 7065648
• MDR Text Key: 93161702
• Report Number: 2023826-2017-01782
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542103145
• UDI-Public: 00841542103145
• 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: 10/30/2017

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: Physician
• Device Expiration Date: 05/31/2019
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/30/2017
• Initial Date FDA Received: 11/28/2017
• Supplement Dates Manufacturer Received: 01/18/2018
• Supplement Dates FDA Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 28 YR