CENTURION SURGICAL PROCEDURE PAK
Report
- Report Number
- 1644019-2024-00865
- Event Type
- Injury
- Date Received
- April 30, 2024
- Date of Event
- March 13, 2024
- Report Date
- December 5, 2024
- Manufacturer
- ALCON RESEARCH, LLC - HOUSTON
- Product Code
- LRO
- PMA / PMN Number
- K880961
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
CORRECTED AND ADDITIONAL INFORMATION WAS PROVIDED IN SECTIONS B.2., B.5., H.6., AND H.11. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.
THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.
ADDITIONAL INFORMATION PROVIDED IN H.6. AND H.11. A SAMPLE WAS NOT RECEIVED AT THE MANUFACTURING SITE FOR EVALUATION; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. NO LOT NUMBER WAS IDENTIFIED WITH THIS COMPLAINT; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED. A SAMPLE WAS NOT RECEIVED AT THE MANUFACTURING SITE AND NO LOT INFORMATION WAS PROVIDED; THEREFORE, THE ROOT CAUSE FOR THE CUSTOMER COMPLAINT ISSUE CANNOT BE DETERMINED. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED WITH THE INFORMATION OBTAINED; THEREFORE, SPECIFIC ACTION WITH REGARDS TO THIS COMPLAINT CANNOT BE TAKEN. COMPLAINTS ARE REVIEWED AND MONITORED AT REGULAR INTERVALS FOR ANY SIGNIFICANT ADVERSE TRENDS. NO ADVERSE TRENDS HAVE BEEN OBSERVED ASSOCIATED WITH THE REPORTED PRODUCT AND EVENT. NO FURTHER ACTIONS ARE REQUIRED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.
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).
ADDITIONAL INFORMATION PROVIDED IN H.6. AND H.11. A SAMPLE WAS NOT RECEIVED AT THE MANUFACTURING SITE FOR EVALUATION; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. NO LOT NUMBER WAS IDENTIFIED WITH THIS COMPLAINT; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED. A SAMPLE WAS NOT RECEIVED AT THE MANUFACTURING SITE AND NO LOT INFORMATION WAS PROVIDED; THEREFORE, THE ROOT CAUSE FOR THE CUSTOMER COMPLAINT ISSUE CANNOT BE DETERMINED. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED WITH THE INFORMATION OBTAINED; THEREFORE, SPECIFIC ACTION WITH REGARDS TO THIS COMPLAINT CANNOT BE TAKEN. COMPLAINTS ARE REVIEWED AND MONITORED AT REGULAR INTERVALS FOR ANY SIGNIFICANT ADVERSE TRENDS. NO ADVERSE TRENDS HAVE BEEN OBSERVED ASSOCIATED WITH THE REPORTED PRODUCT AND EVENT. NO FURTHER ACTIONS ARE REQUIRED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.
ADDITIONAL INFORMATION PROVIDED IN SECTIONS B.5. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.
ADDITIONAL INFORMATION WAS RECEIVED AND REPORTED THAT THEY INTRODUCED MORE VISCOELASTIC AFTER HYDRO DISSECTION TO PROTECT THE ENDOTHELIUM DUE TO THE EDEMA THAT REPORTED, AND REALIZED THAT THIS VISCOELASTIC PRODUCED TEMPORARY OCCLUSION WITHIN THE TIP AND GREATLY INCREASES ITS TEMPERATURE AND CAUSED PERI-INCISIONAL ULCER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
THE EVENTS PERI-INCISIONAL ULCER, PHACO TIP OCCLUSION WERE REMOVED AS THESE WERE SUBMITTED IN OTHER FILE.
A CUSTOMER REPORTED THAT DURING A CATARACT SURGERY UTILIZING AN OPHTHALMIC SYSTEM, PHACOEMULSIFICATION HANDPIECE AND PHACOEMULSIFICATION TIP THE MALE PATIENTS EXPERIENCED CORNEAL BURN, SEVERE DECREASE IN VISUAL ACUITY (VA), AND CORNEAL EDEMA WITH ENDOTHELIAL FOLDS IN LEFT EYE. THE PATIENTS HAD PREEXISTING CONDITIONS INCLUDING OPTIMAL ENDOTHELIAL COUNT AND MEDIUM TO LOW HARDNESS OF CATARACTS. THE SURGEON SUSPECTS THAT THE CORNEAL EDEMA MAY BE RELATED TO EXCESSIVE PARAMETERS (90% TORSIONAL PHACO) AND THE USE OF AN INCORRECT BALANCED NEEDLE FOR MEDIUM-LOW HARDNESS CATARACTS, POTENTIALLY RESULTING IN COLLAPSES. ADDITIONAL TREATMENT, INCLUDING CORTICOSTEROIDS AND ANTI-EDEMA EYE DROPS, WAS ADMINISTERED. ALL PATIENTS ARE CURRENTLY IN THE POST-OPERATIVE RECOVERY PERIOD. THIS COMPLAINT IS PERTAINING THE TWO OF FOUR REPORTS RECEIVED FROM THE INITIAL REPORTER.
ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT WAS PROGRESSED CORRECTLY AND RECOVERED IN A SHORT PERIOD OF TIME AND NO OTHER EPISODE HAS OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2131670 | CENTURION SURGICAL PROCEDURE PAK | GENERAL SURGERY TRAY (KIT) | LRO | ALCON RESEARCH, LLC - HOUSTON | NA | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Other| R | CENTURION SILVER SYSTEM.| CENTURION VISION SYSTEM, ACCESSORY, HANDPIECE.| PHACO TIP. |