CONSTELLATION SURGICAL PROCEDURE PACK
Report
- Report Number
- 1644019-2025-02303
- Event Type
- Malfunction
- Date Received
- July 16, 2025
- Date of Event
- June 7, 2025
- Report Date
- February 22, 2026
- Manufacturer
- ALCON RESEARCH, LLC - HOUSTON
- Product Code
- LRO
- UDI-DI
- 00380657524372
- PMA / PMN Number
- K880961
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- 003
Narratives
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).
CORRECTED INFORMATION PROVIDED IN D.4., H.2. AND H.11. LOT NUMBER WAS UPDATED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
ADDITIONAL INFORMATION PROVIDED IN H.6. AND H.11. NONE RECEIVED: 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. SINCE THE SAMPLE HAS NOT ARRIVED AT SITE THE COMPLAINT FILE WILL BE CLOSED AS A NO SAMPLE RETURNED. IF AND WHEN THE SAMPLE ARRIVES THE COMPLAINT FILE WILL BE REOPENED FOR EVALUATION OF THE SAMPLE. 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 PHOTO ATTACHED WAS REVIEWED BY THE MANUFACTURING SITE. PHOTO IS OF A PAK LABEL WITH THE LOT CODE 176CD4 THAT BELONGS TO QS# (B)(4). REPORTED ISSUE COULD NOT BE CONFIRMED THE PHOTO REVIEW. 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 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 INVESTIGATIVE OR MANUFACTURING ACTIONS ARE NOT WARRANTED AT THIS TIME. A NONCONFORMANCE INVESTIGATION IS CURRENTLY IN PROGRESS TO INVESTIGATE 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. COMPLAINTS ARE REVIEWED AND MONITORED AT REGULAR INTERVALS FOR ANY SIGNIFICANT ADVERSE TRENDS. COMPLAINT DATA FOR ALL COMPANY 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).
ADDITIONAL INFORMATION PROVIDED IN D.9., H.3., H.6. AND H.11. NO TECHNICAL INQUIRIES WERE RECEIVED FROM THE CUSTOMER. ONE OPENED PROBE WITH TIP PROTECTOR IN A ZIP TOP BAG WAS RECEIVED. THE SAMPLE WAS VISUALLY INSPECTED AND FOUND TO BE NONCONFORMING WITH ORANGE/BROWN FOREIGN MATERIAL ON THE PORT FACE, INSIDE THE PORT AND ON THE WELDED CAP AND NEEDLE BENT AT STIFFENER. THE SAMPLE WAS THEN FUNCTIONALLY TESTED FOR ACTUATION AND CUT. THE SAMPLE WAS FOUND TO BE NONCONFORMING FOR BOTH TESTS. THE PROBE WAS DISASSEMBLED AND THE COMPONENTS INSPECTED. EXCESSIVE WEAR OBSERVED ON INNER CUTTER WHEN COMPARED TO THE DEGREE OF WEAR BASED ON CONTINUOUS ACTUATION OF THE PROBE VISUAL STANDARD PHOTOS. INNER CUTTER WAS OBSERVED TO BE BENT. GOUGE MARKS OBSERVED AT AREA THAT WAS BENT, BEND AREA, CUTTING EDGE AND SEVERAL LOCATIONS ALONG THE INNER CUTTER. A REVIEW OF THE DEVICE HISTORY RECORD TRACEABLE TO THE LOT NUMBER OBTAINED FROM THE DEVICE¿S RADIO FREQUENCY IDENTIFICATION (RFID) TAG, 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 PROBE HAD A CUT AND ACTUATION FAILURE. THE ROOT CAUSE FOR THE POOR CUTTING IS THE OBSERVED GOUGE MARKS ON THE CUTTING EDGE, BENT NEEDLE AND BENT INNER CUTTER. THE PROBE WAS DISASSEMBLED, AND THE COMPONENTS INSPECTED. THE WEAR OBSERVED ON INNER CUTTER WHEN COMPARED TO THE DEGREE OF WEAR BASED ON CONTINUOUS ACTUATION OF THE PROBE VISUAL STANDARD PHOTOS IS CONSISTENT WITH EXCESSIVE USE CLASSIFICATION. EXCESS USAGE OF THE PROBE WILL WEAR AND DAMAGE THE INNER CUTTER SUCH THAT THE CUTTER FUNCTION BECOMES POOR, BENT, OR DOES NOT FUNCTION AT ALL. PER THE DIRECTIONS FOR USE (DFU), THE VITRECTOMY PROBE IS VERIFIED FOR TWENTY MINUTES OF USE AT MAXIMUM CUT SPEED. AS THE ROOT CAUSE AND ITS ORIGIN ARE INCONCLUSIVE, FURTHER INVESTIGATIVE OR MANUFACTURING ACTIONS ARE NOT WARRANTED AT THIS TIME AS IT APPEARS THAT THE OBSERVED CUT AND ACTUATION FAILURE, BENT NEEDLE AND BENT INNER CUTTER WERE DUE TO EXCESSIVE USE OF THE PROBE BY THE USER. PER THE DFU, THE VITRECTOMY PROBE IS VERIFIED FOR TWENTY MINUTES OF USE AT MAXIMUM CUT SPEED. A NONCONFORMANCE INVESTIGATION WAS COMPLETED TO INVESTIGATE 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. ANY NON-CONFORMANCES FOUND ARE REMOVED FROM THE LOT AND SCRAPPED. 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 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).
A CUSTOMER REPORTED THAT CUTTER WAS NOT CUTTING DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED BY OPENING ANOTHER PAK. THERE WAS NO PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 151228 | CONSTELLATION SURGICAL PROCEDURE PACK | GENERAL SURGERY TRAY (KIT) | LRO | ALCON RESEARCH, LLC - HOUSTON | NA | 16TPP5 | 00380657524372 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male |