CUSTOM-PAK SURGICAL PROCEDURE PACK
Report
- Report Number
- 1644019-2025-01478
- Event Type
- Injury
- Date Received
- May 15, 2025
- Date of Event
- April 21, 2025
- Report Date
- August 29, 2025
- Manufacturer
- ALCON RESEARCH, LLC - HOUSTON
- Product Code
- LRO
- PMA / PMN Number
- K880961
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION PROVIDED IN B.5. AND H.11. BASED ON NEW INFORMATION RECEIVED, ALL SYMPTOMS HAVE RESOLVED. 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.
CORRECTION INFORMATION PROVIDED IN H.2., H.6 AND H.11. FDA PRODUCT PROBLEMS A24 WAS ADDED, AND CODE A01 WAS REMOVED. 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 PROVIDED IN H.6. AND H.11. PRODUCT EVALUATION WAS NOT ABLE TO BE PERFORMED SINCE THE REPORTED PRODUCT WAS NOT RECEIVED AT THE INVESTIGATION SITE FOR EVALUATION. A REVIEW OF THE REPORTED PAK'S BILL OF MATERIALS (BOM) SHOWS THE SUSPECT PRODUCTS ARE 051-0101SMS GOWN,LARGE,NON REINFORCED AND 051-0101SMSTW GOWN,LARGE,NR,W TOWEL,WRAPPED. A REVIEW OF THE DEVIATION HISTORY REPORT SHOWS THIS LOT DID NOT HAVE A TEMPORARY DEVIATION APPLIED ON THE GOWNS. THE SUPPLIER MANUFACTURER INVESTIGATION CONFIRMED THE GOWNS DO NOT CONTAIN LATEX AND ARE THEREFORE SAFE FOR INDIVIDUALS WITH LATEX SENSITIVITIES. THE INVESTIGATION CONDUCTED A NON-CONFORMANCE REVIEW OF THE REPORTED LOT NUMBER. NO DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THIS EVENT WERE IDENTIFIED AND ALL CORRESPONDING PRODUCTION RELEASE SPECIFICATIONS DEFINED IN THE DEVICE MASTER RECORD WERE MET. THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT IS INCONCLUSIVE. THE INVESTIGATION DETERMINED THERE IS NO RELATIONSHIP OF THE DEVICE TO THE REPORTED INCIDENT. THE INVESTIGATION CONFIRMED THAT THE GOWNS AND THE PAK DID NOT CONTAIN ANY LATEX MATERIALS. NO MANUFACTURING-RELATED DEFICIENCIES WERE FOUND THAT POTENTIALLY COULD HAVE CONTRIBUTED TO THE COMPLAINT. THE FACILITY ENVIRONMENT AND OTHER NON-COMPANY ITEMS THAT ARE PART OF THE SURGICAL SUITE THAT CAME IN CONTACT WITH THE USER DURING THIS REPORTED EVENT. THE ROOT CAUSE FOR THIS COMPLAINT IS NOT KNOWN, THEREFORE, SPECIFIC ACTION WITH REGARDS TO THIS COMPLAINT CANNOT BE TAKEN. 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, NO 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.
BASED ON NEW INFORMATION RECEIVED, ALL SYMPTOMS HAVE RESOLVED.
THE NURSE REPORTED THAT SKIN BREAKOUT WITH REDNESS, ITCHING, AND RAISED RASH ON THE NECK, CHEST, AND JAW. ZYRTEC WAS GIVEN BY MOUTH AND TOPICAL 2.5 HYDROCORTISONE APPLIED TO THE AFFECTED AREA DURING CATARACT [WITH INTRAOCULAR LENS (IOL) IMPLANT] SURGERY. ADDITIONAL INFORMATION RECEIVED THAT THE PATIENT HAD ALLERGIC REACTION. IT COULD BE A LATEX ALLERGY DURING CATARACT [WITH INTRAOCULAR LENS (IOL) IMPLANT] SURGERY. THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 370841 | CUSTOM-PAK SURGICAL PROCEDURE PACK | GENERAL SURGERY TRAY (KIT) | LRO | ALCON RESEARCH, LLC - HOUSTON | NA | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Female | Required Intervention | SURGICAL PRODUCT, UNSPECIFIED. |