MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER INFINITI VISION SYSTEM; UNIT, PHACOFRAGMENTATION

Catalog Number 8065750833

Device Problems Decrease in Suction (1146); Energy Output Problem (1431); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Endophthalmitis (1835); Intraocular Pressure Increased (1937); Loss of Vision (2139); Vitreous Detachment (2445); Capsular Bag Tear (2639); Eye Pain (4467); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/08/2014

Event Type  Injury  

Manufacturer Narrative

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 legal entity reported this patient experienced endophthalmitis, choroidal detachment and phthisis of the left eyeball one month after cataract extraction procedure.The patient was hospitalized.Medication therapies were administered.The patient required an evisceration of the eye with prosthesis.This patient was previously reported to have experienced a posterior capsule tear during the original surgery, this event has been reported earlier in mfr # 2028159-2014-02051.

Manufacturer Narrative

The company service representative examined the system and no problems were found.The phaco handpiece and the cassette were tested and the tests were unremarkable.The system was then tested and met all product specifications.The surgeon refused to use the system.The company service representative replaced the fluidics module and ultrasound card as a diagnostic measure.The system was manufactured on july 17, 2012.Based on assessment, the product met specifications at the time of release.The system was found to meet specifications; therefore, the root cause of the reported event cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

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

Event Description

Additional information has been received from the legal entity.It was reported that the cataract system had broken down, with weakness to no production of ultrasound and an imbalance between irrigation and aspiration.The anterior chamber shallowed and a posterior capsule tear occurred with vitreous prolapse.The handpiece and the cassette were exchanged but did not resolve the issue.A manual anterior vitrectomy had to be performed.An antibiotic was administered as preventative measure.The intraocular lens (iol) was implanted in front of the capsular bag.A suture was placed to seal the incision.Post operative day 1 the patient was prescribed a diuretic for treatment of intraocular hypertension.On that day there was no evidence of infection and no improvement to visual acuity.At 11 days post operative the patient was recommended to take an antibiotic for 1 month.At 1 month post operative visit the patient presented with swelling, redness, vision loss, pain and pus draining from the left eye.Aqueous sample was taken.A vitreous fragment was noted in the incision post operatively.It was noted that the patient had lost visual field on her left side, and continued deterioration to visual acuity.The patient experienced total blindness with enucleation of the eye.

Manufacturer Narrative

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

Manufacturer Narrative

The company representative was unable to confirm nor replicate the reported event.The system was tested and found to meet product specifications.A non-conformance based review of the serial number was performed and did not reveal any potential contributing factors to the reported complaint.A manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for complaints reported against this serial number was performed.No similar complaints were reported for the product serial under investigation.The system was found to meet specifications.Therefore, the root cause of the reported ¿poor ultrasound and unable to aspirate¿ is inconclusive.Based on the information obtained for the other reported events, the root causes were inconclusive.Manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).

• Brand Name: INFINITI VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 8154606
• MDR Text Key: 130027856
• Report Number: 2028159-2018-02580
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K120912
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/07/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065750833
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2017
• Initial Date FDA Received: 12/12/2018
• Supplement Dates Manufacturer Received: 01/02/2019; 03/07/2019; 04/17/2023; 08/09/2023
• Supplement Dates FDA Received: 01/14/2019; 03/19/2019; 05/15/2023; 09/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CUSTOM PAK, BEL.; DUOVISC IBC .5V/.55P CE-F.; SN60WF.210FX, ACRYSOF SP NATURAL IQ FX.; (B)(4), ACRYSOF SP NATURAL IQ FX; CUSTOM PAK, BEL; DUOVISC IBC .5V/.55P CE-F
• Patient Outcome(s): Disability; Required Intervention; Hospitalization
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 73 KG