MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HUNTINGTON ACRYSOF MULTIPIECE IOL; INTRAOCULAR LENS

Model Number MA60MA

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Blurred Vision (2137); Visual Impairment (2138); Wrinkling (2613)

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.(b)(4).

Event Description

A consumer reported that after an intraocular lens (iol) implant surgery, the surgeon noted glistenings and a wrinkle in the iol in the right eye.After the iol implantation the patient first had good vision (visual acuity at nearly 100%).Since 2012, however, the vision has increasingly deteriorated.The patient suffers from the following symptoms: dazzle, loss of contrast and color vision, blurry vision / nebulous vision (like ¿soap¿); had difficulties in driving cars in the night; cannot read anymore; when watching tv only black/white perception and contours but no contrast, only colors red/yellow/green/blue sometimes light up; extreme lightening of metallic items; objects appear smaller.The visual acuity is now at 25 %, in 2014 it has been ca.80-90%.The physicians trace the patient¿s visual impairment back to the glaucoma-induced optic nerve damage and is not blaming the implanted lens.Additional information has been requested.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

New information received from the patient stating she has been in rehabilitation for five (5) weeks due to her glaucoma on the right eye (od).She consulted both the ophthalmologist in the rehabilitation facility and her treating ophthalmologist with respect to her symptoms.In a medical report the optic nerve (papilla) is described like as bald.In addition pigment fittings on the lens and a slight after-cataract were diagnosed.The symptoms are continuing.

• Brand Name: ACRYSOF MULTIPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7524006
• MDR Text Key: 108886202
• Report Number: 1119421-2018-00624
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 08/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2011
• Device Model Number: MA60MA
• Device Catalogue Number: MA60MA.020
• Device Lot Number: 131454
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/23/2018
• Initial Date FDA Received: 05/17/2018
• Supplement Dates Manufacturer Received: 08/01/2018
• Supplement Dates FDA Received: 08/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2006
• 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): Other