MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF IQ NATURAL SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number SN60WF

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Erythema (1840); Irritation (1941); Pain (1994); Visual Impairment (2138); Discharge (2225)

Event Date 02/13/2017

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The results from the product history record review 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 following cataract extraction with an intraocular lens (iol) implant procedure, she experienced worsening of quality of vision, astigmatism, and incorrect splitting of light - she sees light stripes while looking at sun.The surgery was performed approximately 2 months ago.Additional information was provided by the consumer that the day after implantation she had corneal edema.The patient has had atrophia because of inflammation of the optic nerve.After implantation she also experienced eye pain, photophobia.The consumer was using a non- steroidal eye drop and an antibiotic eye drop.She went to the emergency room where she was diagnosed with conjunctival irritation, redness, discharge, and corneal erosion.The ophthalmologist advised the patient to discontinue eye drops.During several visits at various ophthalmologists no specific diagnosis was provided.Astigmatism was stated that was not present prior to the procedure.The patient visited another doctor and started using a non-steroidal eye drop again, together with a steroid drop and a dexapanthenol/polyacrylic polymer combination.Symptoms of splitting of light, redness, and photophobia are continuing.No further information is expected as the consumer does not want doctors to be contacted.

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 6539034
• MDR Text Key: 74253519
• Report Number: 9612169-2017-00075
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.245
• Device Lot Number: 21176785
• Other Device ID Number: 00380655093283
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/07/2017
• Date Device Manufactured: 10/27/2016
• 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: NEVANAC 1MG/ML; VIGAMOX
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR