CONSTELLATION SURGICAL PROCEDURE PACK
Report
- Report Number
- 1644019-2025-05100
- Event Type
- Malfunction
- Date Received
- November 27, 2025
- Date of Event
- October 30, 2025
- Report Date
- February 27, 2026
- Manufacturer
- ALCON RESEARCH, LLC - HOUSTON
- Product Code
- LRO
- UDI-DI
- 00380657524501
- PMA / PMN Number
- K880961
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- 003
Narratives
ADDITIONAL INFORMATION PROVIDED IN B.5 AND H.11. EVENT OCCURRED DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER CHANGING NEW ONE. THERE WAS NO PATIENT IMPACT. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
ADDITIONAL INFORMATION PROVIDED IN H.6. AND H.11. NO TECHNICAL INQUIRIES WERE RECEIVED FROM THE CUSTOMER. A SAMPLE WAS NOT RECEIVED AT THE INVESTIGATION 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. 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. AS THE ROOT CAUSE AND ITS ORIGIN ARE INCONCLUSIVE, FURTHER INVESTIGATION OR MANUFACTURING ACTIONS ARE NOT WARRANTED AT THIS TIME. A NONCONFORMANCE INVESTIGATION HAS BEEN COMPLETED IN RELATION TO THE TREND IDENTIFIED FOR PROBES WITH WOULD NOT CUT OR ACTUATE ISSUES. ALL PROBES ARE 100% 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 COMPANY PRODUCTS IS REVIEWED MONTHLY TO MONITOR 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 TRENDS AND TAKE FURTHER ACTION, AS APPROPRIATE. NO FURTHER ACTION WARRANTED AT THIS TIME. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
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 RECEIVED THAT EVENT OCCURRED DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER CHANGING NEW ONE. THERE WAS NO PATIENT IMPACT.
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT PROBE WAS NO LONGER CUT AT AN UNKNOWN TIMING OF VITRECTOMY SURGERY. THE SURGERY DETAILS WERE UNKNOWN. THERE WAS NO PATIENT IMPACT REPORTED. ADDITIONAL INFORMATION RECEIVED THAT EVENT OCCURRED DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER CHANGING NEW ONE. THERE WAS NO PATIENT IMPACT.
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT PROBE WAS NO LONGER CUT AT AN UNKNOWN TIMING OF VITRECTOMY SURGERY. THE SURGERY DETAILS WERE UNKNOWN. THERE WAS NO PATIENT IMPACT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 601366 | CONSTELLATION SURGICAL PROCEDURE PACK | GENERAL SURGERY TRAY (KIT) | LRO | ALCON RESEARCH, LLC - HOUSTON | NA | 16YR6C | 00380657524501 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |