MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ TORIC SINGLEPIECE IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number SN6AT6

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

Patient Problems Hypopyon (1913); Inflammation (1932); Intraocular Pressure Increased (1937)

Event Date 11/18/2020

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was returned for analysis.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Results from the product history record review indicated the product met release criteria.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that following cataract surgery with an intraocular lens (iol) implantation, the patient is suspected to have developed aseptic endophthalmitis.The iol remains implanted.Additional information was provided indicating that on the 2nd postoperative day, the right eye had strong inflammation.The following day, a hypopyon was confirmed.The patient was treated with antibiotics, steroids, non-steroidal anti-inflammatory and a prostaglandin analog.On the 17th postoperative day the patient had high intraocular pressure (iop), hypopyon and strong inflammation.A diuretic was given for the high iop.Five days later, a re-operation was performed at another hospital.Further information was provided indicating that a vitrectomy and an iol explantation was performed approximately 3 weeks following the initial implantation.Eight days after the reoperation, it was reported that the patient was discharged.

Manufacturer Narrative

Additional information was provided in d.10., h.3., h.6.And h.10.Evaluation summary: the explanted lens was returned submerged in a vial of clear liquid.The lens optic had been cut into two halves, typical of damage observed during removal from the eye.Each optic half contained one fully intact, undamaged haptic.The optic has small cracks near the cut damage.Product history records and batch history records were reviewed and documentation indicated the product met release criteria.Associated products were not indicated.It is unknown if qualified products were used with the lens.The root cause cannot be determined for the reported event.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ TORIC SINGLEPIECE IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 11085929
• MDR Text Key: 224274967
• Report Number: 1119421-2020-02041
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: SN6AT6
• Device Catalogue Number: SN6AT6A125
• Device Lot Number: 12561809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Date Manufacturer Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR