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

Model Number SND1T3

Device Problem Microbial Contamination of Device (2303)

Patient Problems Endophthalmitis (1835); Pain (1994); Visual Impairment (2138)

Event Date 08/27/2020

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.(b)(4).

Event Description

A physician reported that following a cataract surgery with an intraocular lens (iol) implantation, the patient felt eye pain and decreased vision.Eight days later, the patient was admitted to hospital; their visual acuities were checked as 0.2 and the symptoms were initial diagnosed as intraocular infection.Additional information was provided indicating that the patient was admitted to the hospital a second time and underwent a vitrectomy.At present, the patient's vision has improved.Further information was reported that the hospital could not provide further relevant medication treatment due to privacy of the patient.For the conclusion that the patient's endophthalmitis was caused by lens, the hospital reported that they had tested all aspects of the operation, but no bacterial source was found.After that, two new unopened iols were sent to a third-party inspection company, and micrococcus luteus was detected on the surface of one of the crystals.Therefore, it was considered that endophthalmitis was caused by lens.

Manufacturer Narrative

Evaluation summary: the lens remains implanted.Product history and sterilization records were reviewed and documentation indicated the product met release criteria including package sealing and sterilization.The root cause for the reported endophthalmitis could not be determined.The lens remains implanted.The hospital stated it could not provide relevant medication and treatment information due to patient privacy.A new unopened iol was sent to a third-party inspection company, and micrococcus luteus was detected on the surface of one of the lenses.Micrococcus luteus is a common contaminant of microbial testing due to failures in aseptic technique.The manufacturer's terminal sterilization cycle which is validated to demonstrate 6 log reduction (1,000,000 cfu) in the challenge spores would not permit survival of the bacteria micrococcus luteus.The challenge spores (bacillus atropheus) are the most resistant bacteria to eto sterilization, which are far more resistant than micrococcus luteus.The sterilization cycle for this specific lot/batch met all release criteria.The validated terminal sterilization cycle ensures adequate sterilization.Therefore, a root cause related to inadequate sterilization can be excluded/highly unlikely.The manufacturer internal reference number is: (b)(4).

Event Description

Follow-up information was provided by the reporting facility that cultures from the last surgery were negative.

• Brand Name: ACRYSOF RESTOR 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: 10800550
• MDR Text Key: 215025920
• Report Number: 1119421-2020-01622
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): N
• PMA/PMN Number: P040020
• 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: 12/29/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: SND1T3
• Device Catalogue Number: SND1T3T135
• Device Lot Number: 12473977
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/19/2020
• Initial Date FDA Received: 11/06/2020
• Supplement Dates Manufacturer Received: 12/17/2020
• Supplement Dates FDA Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention