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

Model Number MICL12.1

Device Problem Misfocusing (1401)

Patient Problems Cataract (1766); Foreign Body Sensation in Eye (1869); Itching Sensation (1943); Blurred Vision (2137); Excessive Tear Production (2235); Eye Pain (4467)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The reporter indicated that the surgeon implanted a 12.1mm micl12.1 implantable collamer lens, -10.0 diopter, into the patient's right (od) eye on (b)(6) 2009.Reportedly, the patient developed lens opacity cortical, refractive change over time, the patient had to wear glasses to drive, a watery/itching/poking feeling and pain in the eye.Blurry vision also reported.The surgeon states the patient's acd changed from 3.93 in 2009 to 3.39 in 2020.The patient's axial length increased."no one has control over that!".

Manufacturer Narrative

H6 - type of investigation 3331 - device history record (dhr) review: based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within established process parameters and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.Claim#: (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
• MDR Report Key: 11620596
• MDR Text Key: 243988253
• Report Number: 2023826-2021-00861
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 03/10/2021

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: 11/30/2009
• Device Model Number: MICL12.1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/10/2021
• Initial Date FDA Received: 04/06/2021
• Supplement Dates Manufacturer Received: 06/09/2021
• Supplement Dates FDA Received: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other