MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ PANOPTIX TORIC UV ABSORBING TRIFOCAL IOL; LENS, MULTIFOCAL

Model Number	TFAT50
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Corneal Edema (1791); Hemorrhage/Blood Loss/Bleeding (1888); Keratitis (1944); Blurred Vision (2137); Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history records could not be reviewed because the reporter did not provide a lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that following an cataract surgery with intraocular lens (iol) implant procedure, on day one of post op, the patient presented with an iatrogenic 360 subconjunctival heme (used the lensx) patient was unhappy.Visual acuity with encouragement was 20/80.The patient had some corneal edema, the pupil was still dilated and the iol looked to be 5-10 degrees off.Reassured the patient and had her come back on post op day 4.The patient was still unhappy with diffuse superficial punctate keratitis (spk).Visual acuity is 20/60 near j4 but only with encouragement.Intraocular pressure has been fine in the low-mid teens.The patient is no longer dilated but her iol appears to be well centered.The patient was wearing her old glasses with the left lens removed and reading a pamphlet when walked in the room.The patient is indifferent not mad or angry but not happy.

• Brand Name: ACRYSOF IQ PANOPTIX TORIC UV ABSORBING TRIFOCAL IOL
• Common Device Name: LENS, MULTIFOCAL
• 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: 14187783
• Report Number: 1119421-2022-00829
• Device Sequence Number: 4459016
• Product Code: MFK
• UDI-Device Identifier: 00380652419765
• UDI-Public: 00380652419765
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/22/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: TFAT50
• Device Catalogue Number: TFAT50.200
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2022
• Initial Report FDA Received Date: 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LENSX LASER SYSTEM
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Sex: Female