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

Model Number MICL12.1

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

Patient Problems Cataract, Induced (1767); Corneal Edema (1791); Hyphema (1911); Intraocular Pressure Increased (1937); No Code Available (3191)

Event Date 10/10/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Lens not returned.

Event Description

The reporter stated that the surgeon implanted a 12.1mm micl12.1 lens, -3.50 diopter, in the patient's right eye on (b)(6) 2016.The lens was explanted on the same day due to excessive vaulting, resulting in elevated intraocular pressure (iop), shallow anterior chamber, corneal edema, hyphema, and development of a cataract.

Manufacturer Narrative

Device evaluation: product evaluation found that the lens was returned in liquid in the lens vial.Visual inspection found a small tear on the haptic.(b)(4).

• Brand Name: ICL (IMPLANTABLE COLLAMER LENS)
• Type of Device: 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: michelle andres ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 6054105
• MDR Text Key: 58294218
• Report Number: 2023826-2016-01523
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542102629
• UDI-Public: (01)00841542102629(17)170131
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/10/2016

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: 01/31/2017
• Device Model Number: MICL12.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/10/2016
• Initial Date FDA Received: 10/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2015
• 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
• Treatment: CARTRIDGE MODEL UNK, LOT NUMBER UNK; INJECTOR MODEL UNK, LOT NUMBER UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR