MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL; INTRAOCULAR LENS

Model Number	DFT315
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Visual Impairment (2138); Visual Disturbances (2140); Halo (2227)
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that, following the cataract surgery with intraocular lens (iol) implant procedure, the patient experienced streak of light like a lighthouse on seeing any bright light.Even small led light , or even a reflection on any object.The patient also stated this is very disturbing in fact distressing particularly at night on the road.Additional information was received stating the fact that the streak was identical for both eyes (near horizontal, slightly tilted upwards on patient's right and downwards on the left side) indicates that something was wrong with the lens.
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.Associated products were not provided.It is unknown if qualified products were used.There have been no other complaints reported in the lot number.The product investigation could not identify a root cause.Each lens is subjected to a 100% assessment of the power (spherical and cylinder) and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received and stated that the, patient had intraocular pressure of 25 mmhg.On (b)(6) 2023 the patient was admitted and discharged on the same day.The patient was complaints of gradual fall of vision and was diagnosed with left eye cataract.The patient was given left eye with mics (micro incision cataract surgery) with pc iol implantation (imported foldable, extend depth of focus, toric lens) under local anaesthesia.Anti inflammatory drug, antibiotic eye drop, ophthalmic lubricants eye drop, artificial tears gel once daily before bed, tab on-steroidal anti-inflammatory drugs take only in case of pain.
Additional Manufacturer Narrative
Correction: on smdr 1 the patient code of 2227 and 1937 were submitted by an error.These event have been removed as these events happened before and during the cataract surgery without casual relationship with the iol.The product was not returned.The incorrect lot number was initially provided.The corrected lot number was received.Product history records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause for the reported complaint.The product was not returned.Each lens is subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Information was provided that the surgeon explained about the different lenses and the procedures.The surgeon suggested a monofocal lens for the second eye, but the patient chose to go with a company model lens.Surgeon offered to explant the company and replace with a monofocal lens.The patient has declined at this time.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Upon further review of the previous information, it was identified that, the event of gradual fall of vision was the patient current complaint at the time of the cataract surgery (pre-operative).The patient was given left eye with micro incision cataract surgery (mics) was actually a cataract surgery performed for left eye and iol 25 mmhg was of before surgery.The patient was treated with medication (anti-inflammatory drug, antibiotic eye drop, ophthalmic lubricants eye drop, artificial tears gel once daily before bed, tab on-steroidal anti-inflammatory drugs take only in case of pain) during the cataract surgery.Hence events codes have been removed as iol was not the contributory cause.

• Brand Name: ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 16511746
• Report Number: 1119421-2023-00423
• Device Sequence Number: 6758747
• Product Code: POE
• UDI-Device Identifier: 00380652421706
• UDI-Public: 00380652421706
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/17/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/05/2025
• Device Model Number: DFT315
• Device Lot Number: 15112350
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2023
• Supplement Date Received by Manufacturer: 03/12/2023; 06/19/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 04/10/2023; 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 77 YR
• Patient Sex: Male