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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Intraocular Pressure, Delayed, Uncontrolled (1936); Pain (1994); Visual Impairment (2138); Vomiting (2144); No Code Available (3191)

Event Date 08/10/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Received a voluntary event report from the fda - # mw5064619.The patient reported had micl implantable collamer lenses, implanted bilaterally on (b)(6) 2016.The patient reported excruciating pain and was unable to see out of her left eye.The patient was admitted into hospital, where a surgical iridotomy was performed to release the pressure in the eye.The patient's eye was lasered several times to release the pressure.The patient was in pain and was vomiting.The patient returned to her ophthalmologist and a glaucoma specialist, and after a couple weeks of treatments - synthroid, pred forte, dorzolmide and zyrtec, the va in her left eye was 20/60 and the pain was decreased.The lens remains implanted.

• 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: 6042660
• MDR Text Key: 57916936
• Report Number: 2023826-2016-01497
• 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: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/26/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/26/2016
• Initial Date FDA Received: 10/19/2016
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization; Required Intervention