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 Corneal Scar (1793); Headache (1880); Visual Disturbances (2140); Discomfort (2330); Eye Burn (2523); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/09/2018

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 customer reported at the beginning of the phacoemulsification mode a white cloud appeared and the patient experienced a corneal burn at the incision during a cataract extraction procedure.The placement of a suture was required to close the wound.A completed questionnaire was received.The surgeon indicated the burn occurred during the sculpting of the cataract.There was shallowing of the anterior chamber which caused iris damage.An occlusion alarm was not noted by the surgeon.Post surgery the surgeon noted irregular astigmatism, and corneal scarring in the superior cornea which has persisted beyond the one month post operative period.Further treatment of nonsteroidal anti-inflammatory drugs and corticosteroids was required.Current patient prognosis is unknown.Additional information has been reviewed in the questionnaire.The patient had to undergo an additional procedure for the treatment of iridocorneal synechia.Additional information has been received from medical expert examination indicated the cornea was clear and the anterior segment was calm.The iris showed as deformed with synechia at 12 o'clock.The implant is well positioned and in place.The fundus exam has showed normal.The patient has been prescribed an artificial tear.It was noted in the new information that the operating surgeon had doubts about the phaco handpiece.This is one of two reports for this issue and represents the ophthalmic system.

Manufacturer Narrative

Additional information has been provided in h.6 and h.10.The specific product identifiers (lot number, batch number, and/or serial number) were not provided and could not be determined at this time.However, all device history records are reviewed prior to product release to ensure the product was manufactured in compliance with the device master record and meets release criteria.The lot/batch/serial is unknown; therefore, a service history review cannot be performed.The root cause cannot be determined conclusively.The 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).

Manufacturer Narrative

Corrected information has been provided in section b.5.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported at the beginning of the phacoemulsification mode a white cloud appeared and the patient experienced a corneal burn at the incision during a cataract extraction procedure.The placement of a suture was required to close the wound.A completed questionnaire was received.The surgeon indicated the burn occurred during the sculpting of the cataract.There was shallowing of the anterior chamber which caused iris damage.An occlusion alarm was not noted by the surgeon.Post surgery the surgeon noted irregular astigmatism, and corneal scarring in the superior cornea which has persisted beyond the one month post -operative period.Further treatment of nonsteroidal anti-inflammatory drugs and corticosteroids was required.Current patient prognosis is unknown.Additional information has been reviewed in the questionnaire.The patient had to undergo an additional procedure for the treatment of iridocorneal synechia.Additional information has been received from medical expert examination indicated the cornea was clear and the anterior segment was calm.The iris showed as deformed with synechia at 12 o'clock.The implant is well positioned and in place.The fundus exam has showed normal.The patient has been prescribed an artificial tear.It was noted in the new information that the operating surgeon had doubts about the phaco handpiece.This is one of two reports for this issue and represents the ophthalmic system.

Manufacturer Narrative

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

Event Description

Additional information received indicating that on the follow up visit, they have observed descemet folds, quite anterior chamber and acuity without correction.Patient also experienced photophobia in the left eye, pain, headache, difficulty in reading, screen doubles for television and sensation of sand in the eye post operatively.This is one of two reports for this issue and represents the ophthalmic handpiece.

• 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: 12408288
• MDR Text Key: 269361970
• Report Number: 2028159-2021-00974
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/13/2023

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?: No
• 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
• Initial Date Manufacturer Received: 08/12/2021
• Initial Date FDA Received: 09/01/2021
• Supplement Dates Manufacturer Received: 12/24/2021; 01/19/2022; 04/18/2023
• Supplement Dates FDA Received: 01/14/2022; 02/09/2022; 05/13/2023
• 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: CENTURION VISION SYSTEM.; STAR KS-SP YELLOW LENS IMPLANT, POWER +24D.; CENTURION VISION SYSTEM; STAR KS-SP YELLOW LENS IMPLANT, POWER +24D
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female