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 Conjunctivitis (1784); Endophthalmitis (1835); Inflammation (1932); Swelling (2091)

Event Date 12/06/2018

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was not 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.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that two days following a cataract extraction with an intraocular lens (iol) implant procedure, the patient was diagnosed with endophthalmitis.A vitreous cavity puncture injection + anterior chamber were performed.The following day a vitrectomy was performed.Eight days later, a vitreous cavity lavage, intraocular lens extraction and silicone oil filling were performed.Additional information was provided indicating that the patient had vitreous inflammation, conjunctival redness and swelling.Routine blood examination was performed.No infectious hemogram.A culture was performed.The event resulted in clinically significant visual change.The interventions performed were effective.The outcome of the event resolved.The patient recovered with persistent condition.

Manufacturer Narrative

Evaluation summary: the product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.The product investigation could not identify a root cause.There is one other complaint in this lot.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: 8761608
• MDR Text Key: 150108734
• Report Number: 1119421-2019-01050
• 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: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: SN6AT6
• Device Catalogue Number: SN6AT6.245
• Device Lot Number: 12538614
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BALANCED SALT SOLUTION; FMS; POVIDONE IODINE 10%; REUSABLE TUBING; SUTURES; UNSPECIFIED DROPS OR INJECTIONS; VISCOELASTIC EVE
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR