MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACROSOF IQ IOL; INTRAOCULAR LENS

Lot Number 15174233 080

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

Patient Problem Unspecified Eye / Vision Problem (4471)

Event Date 07/22/2021

Event Type  Injury  

Event Description

Alcon defective iol.I had glaucoma surgery performed by dr.(b)(6).Upon the recommendation of dr.(b)(6) he removed my natural lens in my left eye and implanted a interoccular lens (iol) manufactured by alcon industries.The incorrect lens was inserted in my left eye after i explicitly informed dr.(b)(6) and his staff that i did not want short distance lens.I specifically request a intermediate lens.This defective iol has caused multiple abberations including glare, halos, and glistening.I notice the glistening around the perimeter of the iol inside my eye primary during the evening when there is a light source.This glistening can occur 15 to 20 times a day which is very disturbing.The iol specifications data, make and model is as follows: manufacturer: alcon industries make/model: acrysof iq iol serial #: (b)(4) udi-(b)(4) mr#41228 date implanted: (b)(6) 2021 physician: dr.(b)(6) as a result of the defects of this lens i have been experiencing physical and mental complications.I am currently seeing a psychiatrist since attempting to remove this lens is a major risk.I have been diagnosed with fuchs dystrophy and uveitis.The conditions existed prior to the glaucoma surgery.However after consulting with dr.(b)(6) he recommended that my natural lens be removed and an iol implanted despite not having a severe cataract.I was under the care of dr.(b)(6) (opthamologist in (b)(6)) for 4 months prior to this surgery and he never stated that i had a problem with cataracts.Therefore the iol should never have been implanted.Similar iol history has been documented to has caused eye abberations in patients.It lens is made of acrylic and microvacuole voids can form located in the iol bulk filled with the fluid surrounding the iol.As an engineer my eyesare critical to my livelihood and k researched case studies from (b)(6) that validate this phenomenon in alcon acrylic iols.I have contacted the alcon quality control department and they were not concern about the complications that i am having.The alcon representative (mr.(b)(6), quality control mgr.) located (b)(6) stated alcon would conduct a investigation at the vold eye clinic to determine if other patients have experienced these types of complications.I asked if i could get the result of the report and any findings, however mr.(b)(6) stated that this information had to kept confidential.I am requesting this information be made public (foi) to seek medical correction and to prevent other from experiencing the same complications.Mr.(b)(6) stated that they have not had any other complaints regarding this alcon iol.As an engineer my eyesight is critical to my livelihood.Product can have defect despite the best qa/qc program.I contend that the iol that was implanted is defective and could be an anomaly.Here's mr.(b)(6) contact information: (b)(6).I am asking that the fda further investigate the batch no.Of these iols for defects.Alcon would not accept my verbal communication stating that i have abbrerarions and their product is defective.I will be visiting an specialist on (b)(6) 2021 to detect the glare, double vision, glistening.There have been several case studies performed that provide evidence that the alcon acrylic lens have a tendency to have abberations.I can provide these case studies upon demand.Thank you in advance for your support regarding this important matter.Sincerely, (b)(6).Testing will be conducted on (b)(6) 2021 by dr.(b)(6) (opthamologist) in (b)(6).I will send the result to the fda.Give best estimate of duration 150 day.

• Brand Name: ACROSOF IQ IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.
• MDR Report Key: 13019739
• MDR Text Key: 282420893
• Report Number: MW5106108
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/14/2021

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 Lot Number: 15174233 080
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/15/2021
• Patient Sequence Number: 1
• Treatment: 'S': 2 X DAY LOTEMAX: 4/3/2/1 EACK WEEK VYZULTAEYE: DROP 1X NIGHT SIMBREZA: 2 X DAY; CELLCEPT 500 MG BID: 2 X; DAY PLAQUENIL 200 MG BID ; EYE DROP FOR DRY EYES; OTHER EYE DROPS YOU HAVE WITH YOU IE BETAXOLOL ; PREDNISONE 15 MG ONCE A DAY ; SIMBICORT 1 PUFF BID ; XIIDRA 1 DROP EACH EYE BID 2 X DAY
• Patient Outcome(s): Disability
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American