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

Model Number AU00T0

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

Patient Problem Unspecified Infection (1930)

Event Date 08/08/2019

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The product investigation could not identify a root cause.Additional information has been requested.The manufacturer internal reference number is: (b)(4).

Event Description

A health professional reported that after an intraocular lens (iol) implant surgery, a patient experienced an infection.The reporter explains that the service is investigating where the contamination is coming from and that the operating room will be completely sterilized.Additional information has been requested.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.Viscoelastic was not provided.It is unknown if a qualified product was used.The product investigation could not identify a root cause.It is unknown if a qualified viscoelastic was used.Material properties of non-qualified ovds may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information has been received stating she could not tell what product was suspected since they had an hygrometric issue in the operating room.It was too high and it could have altered sterility of the boxes.Therefore, they have reported this incident by precaution but the hygrometric issue may have been the cause of the infection.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

New information received form the customer stating the prognosis is poor.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

Additional information has been received stating the patient has been diagnose with endophthalmitis.The patient has lost visual functions in the infected eye.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

Additional information received form the customer stating neither the surgeon or the hospital believe that any alcon product caused or contributed to the event.They believe the root cause was elevated temperature in the or.The surgeon and hospital remain confident in alcon products and happy with the business relationship.

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM
• Type of Device: LENS, GUIDE, INTRAOCULAR
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 8906272
• MDR Text Key: 154737090
• Report Number: 1119421-2019-01324
• Device Sequence Number: 1
• Product Code: KYB
• 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,Followup,Followup,Followup
• Report Date: 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: AU00T0
• Device Lot Number: 12596841
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CEFUROXIME 50MG; CHIBROCADRON; VISTHESIA
• Patient Outcome(s): Other