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

Model Number SN60AT

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

Patient Problems Corneal Edema (1791); Endophthalmitis (1835); Pain (1994)

Event Date 01/28/2019

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

Event Description

A physician reported that ten days following a cataract/vitrectomy/intraocular lens (iol) implant procedure, the patient developed endophthalmitis.The treatment is still under observation.Additional information was provided indicating that after six days of hospitalization, the patient was discharged, the intraocular pressure was normal, the cornea was transparent, the pupil was 3mm, the light reaction was normal, the iol was positioned correctly, the gas in the vitreous body was clear below, and the retina was normal.The day after discharge, the patient experienced eye pain.The diagnosis was endophthalmitis with hospitalization.The vision was sensitive, the anterior chamber exuded, the pupil exuded membrane, the lens was in place, the fundus peeped unclearly and b-mode ultrasonography showed high echo in the vitreous cavity.A local anti-inflammation was given.Performed anterior chamber lavage and intravitreous injection of antibiotics.Three days later, the symptoms worsened and performed intravitreal lavage and iol removal surgery.After surgery, the whole body and local anti-infection were performed.At present, the patient's condition is stable, the vision is 0.12, the cornea is slightly edematous, the pupil is 3 mm, the lens is absent, the silicone oil in the vitreous cavity is clear, the fundus of the eye is occlusive, the macular temporal swelling is about 6 pd, and the remaining retina is in position.

Manufacturer Narrative

Evaluation summary: the lens was returned adhered to a small piece of paper.Viscoelastic and a small amount of blood are observed.The optic has been cut from the edge to the center.The root cause for the reported events could not determined.The returned lens was evaluated.Damage was observed which is typical of a removal.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF SINGLEPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 8371582
• MDR Text Key: 137233965
• Report Number: 1119421-2019-00235
• Device Sequence Number: 1
• Product Code: HQL
• 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: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: SN60AT
• Device Catalogue Number: SN60ATC220
• Device Lot Number: 12547847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2019
• Date Manufacturer Received: 05/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR