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

Catalog Number ASKU

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

Patient Problems Conjunctivitis (1784); Corneal Edema (1791); Endophthalmitis (1835); Hypopyon (1913); Uveitis (2122); Visual Impairment (2138); Toxic Anterior Segment Syndrome (TASS) (4469); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/14/2022

Event Type  malfunction  

Event Description

A physician reported that after cataract surgery by using an irrigation/aspiration (i/a) handpiece and phacoemulsification handpiece, a patient experienced severe endophthalmitis or toxic anterior segment syndrome (tass) with functional loss of eye.Additional related information was requested but has not been provided to date.This is the third of three reports for the reported event from this facility.

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

Based on the information received following submission of the initial report, suspect product is a re-usable ophthalmic handpiece and not irrigation/aspiration handpiece.

Manufacturer Narrative

Based on the information received following submission of the initial report, suspect product is a re-usable ophthalmic handpiece and not irrigation/aspiration handpiece.The updated report for the suspected re-usable ophthalmic handpiece has been submitted under mfg report num.2523835-2022-00344.No further reports will be scheduled under mfg report num.2028159-2022-01142.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Upon additional corrected information received, the previously reported fda patient code "4469" was not experienced by the patient.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information received indicating that the cataract surgery was completed without complications.The patient presented with endophthalmitis two days after the surgery.The patient presented with conjunctival inflammation: 3+; cells in the anterior chamber: 3+; fibrin in the anterior chamber; and hypopyon.The patient had pain, edema of the upper eyelid, and cyclitic membrane preventing examination of the vitreous.The patient went to the emergency room and was hospitalized for seven days and had intravitreous injection of antibiotics, glucocorticoid bolus injection, intravitreous injection of corticosteroid, steroid in sub conjunctival form.The action was effective.The patient¿s visual acuity recovered to normal and all the symptoms have been resolved.This is the third of three reports for the reported event from this facility.

• Brand Name: CENTURION VISION SYSTEM, ACCESSORY, HANDPIECE
• 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: 15198684
• MDR Text Key: 297622339
• Report Number: 2028159-2022-01142
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K121555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: BETADINE 10% ON THE EYELIDS: PRE-OP TREATMENT; CENTURION VISION SYSTEM; CENTURION VISION SYSTEM, ACCESSORY, HANDPIECE; CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM; DUOVISC VISCOELASTIC SYSTEM; IRRIGATION SOLUTION USED: BSS + ADRENALINE; OCULAR 5% FOR 3 MINUTES: PRE-OP TREATMENT; STERITRIP: PRE-OP TREATMENT
• Patient Age: 76 YR
• Patient Sex: Female