MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number	AU00T0
Medical Device Problem Codes	Defective Component (2292); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Corneal Edema (1791); Inflammation (1932); Visual Disturbances (2140); Fibrosis (3167)
Date of Event	06/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A health care professional reported that, during the intraocular lens implant (iol) procedure, when physician implanted, he noticed that a haptic has broken.When he was ready to take the lens with a clip to remove it from the eye, he noticed that as he hold the lens with the clip, the lens is undone into pieces.The lens was broken down in the eye.He finally managed to remove all the lens fragments.Additional information received and stated that, impact on the patient was lengthening of the surgical act when having to explant the lens.Pain during surgery and major post-surgical inflammation.No total visual recovery after one month, with edema / endothelial fibrosis.Maximum corrected visual acuity one month after the intervention was 0.4.With new lens implanted in the same surgical act.The lens when implanted it was observe that the haptic is broken, but what is surprising is that when explanting the iol it breaks as soon as it touches it with the clamp of tech.The manual implant was performed at physician indication.The lenses unfold very abruptly and we have had complications with rupture of the posterior chamber, in eyes already more difficult.The behavior of the iol material was absolutely pathological, it was fragmented into more than four or five pieces that it had to bring manually, with the consequent corneal inflammation, which today lasts and we do not know if it will require intervention at the corneal level.

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM
• 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: 17596383
• Report Number: 1119421-2023-01502
• Device Sequence Number: 12617751
• Product Code: HQL
• UDI-Device Identifier: 00380652394864
• UDI-Public: 00380652394864
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/22/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/19/2025
• Device Model Number: AU00T0
• Device Lot Number: 15495843
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2022
• 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: MONARCH III CARTRIDGE C; MONARCH III INJECTOR
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR
• Patient Sex: Male