CONSTELLATION SURGICAL PROCEDURE PACK
Report
- Report Number
- 1644019-2025-00224
- Event Type
- Malfunction
- Date Received
- January 16, 2025
- Date of Event
- December 30, 2024
- Report Date
- July 24, 2025
- Manufacturer
- ALCON RESEARCH, LLC - HOUSTON
- Product Code
- LRO
- UDI-DI
- 00380657531066
- PMA / PMN Number
- K880961
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION PROVIDED IN B.5, D.4, 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.
ADDITIONAL INFORMATION PROVIDED IN D.4., 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. A REVIEW OF THE DEVICE HISTORY RECORD TRACEABLE TO THE REPORTED LOT NUMBER, INDICATES THAT THE REPORTED PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE REPORTED PRODUCT¿S ACCEPTANCE CRITERIA. A SAMPLE WAS NOT RECEIVED AT THE MANUFACTURING SITE AND THE DEVICE HISTORY RECORD REVIEW OF THE LOT NUMBER PROVIDED INDICATED THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTABLE CRITERIA, THEREFORE; THE ROOT CAUSE FOR THE CUSTOMER COMPLAINT ISSUE CANNOT BE DETERMINED. THE EXACT ROOT CAUSE FOR THIS COMPLAINT IS UNKNOWN; THEREFORE, SPECIFIC ACTION WITH REGARDS TO THIS COMPLAINT CANNOT BE TAKEN. ALL PROBES ARE HUNDRED PERCENT VISUALLY INSPECTED AND TESTED FOR ACTUATION, ASPIRATION, AND CUT DURING MANUFACTURING. 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 D.9., H.3., H.6. AND H.11. ONE OPENED PROBE WAS RECEIVED WITH TUBING CUT AND NO RADIO FREQUENCY IDENTIFICATION RETURNED, WITH A TIP PROTECTOR, IN A BAG. THE SAMPLE WAS VISUALLY INSPECTED AND FOUND TO BE NONCONFORMING WITH ORANGE/BROWN FOREIGN MATERIAL IN THE PORT. THE SAMPLE WAS THEN FUNCTIONALLY TESTED FOR ACTUATION AND CUT. THE SAMPLE WAS FOUND TO BE NONCONFORMING FOR ACTUATION AND CUT. THE PROBE WAS DISASSEMBLED, AND THE COMPONENTS INSPECTED. NOMINAL WEAR OBSERVED ON INNER CUTTER WHEN COMPARED TO THE DEGREE OF WEAR BASED ON CONTINUOUS ACTUATION OF THE PROBE VISUAL STANDARD PHOTOS. GOUGE MARKS OBSERVED AT BENT AREA AND COUPLE LOCATIONS ON THE INNER CUTTER. THE SAMPLE WAS RETESTED FOR ACTUATION WITH THE PROBE DRIVER AND WAS DEEMED NONCONFORMING. NEEDLE HOLDER AND RETAINER WERE DISASSEMBLED AND VISUALLY INSPECTED. THERE WAS NO DAMAGE OR FLASH TO THE O-RING OR NEEDLE HOLDER. PRESENCE OF SILICONE WAS OBSERVED ON THE O-RING. ENGINE WAS DISASSEMBLED, O-RINGS SPACER AND DIAPHRAGM WERE FOUND TO BE ALL INTACT. A REVIEW OF THE DEVICE HISTORY RECORD TRACEABLE TO THE REPORTED LOT NUMBER, INDICATES THAT THE REPORTED PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE REPORTED PRODUCT¿S ACCEPTANCE CRITERIA. THE INVESTIGATION CONDUCTED A NON-CONFORMANCE REVIEW OF THE REPORTED LOT NUMBER. NO DEVIATIONS WERE IDENTIFIED, AND ALL CORRESPONDING PRODUCTION RELEASE SPECIFICATIONS DEFINED IN THE DEVICE MASTER RECORD WERE MET. BASED ON THE EVALUATION OF THE INFORMATION AND MATERIALS RECEIVED, THE INVESTIGATION WAS UNABLE TO IDENTIFY THE ROOT CAUSE OR ORIGIN OF THE REPORTED EVENT. ADDITIONALLY, NO MANUFACTURING-RELATED DEFICIENCIES WERE FOUND THAT POTENTIALLY COULD HAVE CONTRIBUTED TO THE COMPLAINT. THE COMPLAINT EVALUATION CONFIRMS THAT THE PROBE HAD A CUT FAILURE, AND THE EVALUATION ALSO INDICATED THAT THE PROBE HAD AN ACTUATION FAILURE. THE EXACT ROOT CAUSE OF THE CUT AND ACTUATE FAILURES CANNOT BE DETERMINED FROM THE EVALUATION PERFORMED. AS THE ROOT CAUSE AND ITS ORIGIN ARE INCONCLUSIVE, FURTHER INVESTIGATIVE OR MANUFACTURING ACTIONS ARE NOT WARRANTED AT THIS TIME. ALL PROBES ARE HUNDRED PERCENT VISUALLY INSPECTED AND TESTED FOR ACTUATION, ASPIRATION, AND CUT DURING MANUFACTURING. RECEIPT OF ADDITIONAL RELEVANT INFORMATION OR SUPPORTING MATERIALS WILL PROMPT A RE-EVALUATION OF THE COMPLAINT INVESTIGATION. COMPLAINT DATA FOR ALL PRODUCTS IS REVIEWED MONTHLY TO MONITOR FOR ADVERSE TRENDS. DURING THE LAST REVIEW, ADVERSE TRENDS WERE OBSERVED FOR THE REPORTED PRODUCT AND EVENT COMBINATION. QUALITY ASSURANCE HAS REVIEWED THIS COMPLAINT AND WILL CONTINUE TO MONITOR DATA FOR EVIDENCE OF ADVERSE TRENDING AND TAKE FURTHER ACTION, AS APPROPRIATE. NO FURTHER ACTION WARRANTED 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.
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). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.
ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED THAT THE VITRECTOMY SURGERY WAS COMPLETED ON SAME DAY BY REPLACING THE PROBE. THERE WAS NO PATIENT IMPACT.
A PHYSICIAN REPORTED THAT THE VITRECTOMY PROBE DID NOT CUT RELIABLY DURING SURGERY. THE PROCEDURE DETAILS WERE UNKNOWN. NO PATIENT IMPACT WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED NONE RECEIVED TILL DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1952802 | CONSTELLATION SURGICAL PROCEDURE PACK | GENERAL SURGERY TRAY (KIT) | LRO | ALCON RESEARCH, LLC - HOUSTON | NA | 16V504 | 00380657531066 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |