SILIKON 1000 OIL
Report
- Report Number
- 1610287-2022-00034
- Event Type
- Injury
- Date Received
- May 24, 2022
- Report Date
- January 4, 2023
- Manufacturer
- ALCON RESEARCH, LLC
- Product Code
- LWL
- UDI-DI
- 00380656011873
- PMA / PMN Number
- P950008
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- 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).
THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
ADDITIONAL INFORMATION IS PROVIDED IN SECTIONS H.6 AND H.10. NO LOT CODE WAS REPORTED BY THE CUSTOMER; THEREFORE, LOT SPECIFIC EVALUATION CANNOT BE COMPLETED. ALL COMPOUNDING, PREPROCESSING, FILLING AND PACKAGING MBRS ARE SUBJECTED TO 2 INDEPENDENT REVIEWS. IN ADDITION, THE FOLLOWING ARE REVIEWED: ALL CHEMISTRY AND MICROBIAL FINISHED PRODUCT RESULTS. ENVIRONMENTAL, UTILITY, BIOBURDEN RECORDS. SANITIZATION RECORDS. STERILIZATION CYCLES. THE PRODUCT IS COMPOUNDED BY (1) CHEMICAL AND THERMAL EXTRACTION, AND (2) STERILE FILTRATION OF OIL PRIOR TO FILLING. THE PRODUCT IS THEN FILLED INTO ITS PRIMARY PACKAGING COMPONENTS USING ASEPTIC PROCESSING. THE PRODUCT'S 10 ML GLASS BOTTLES AND THE STOPPERS ARE MADE FROM SILICONE; THE PRODUCT IS FILLED ON LINE 21. THE PRODUCT IS TERMINALLY STERILIZED USING DRY HEAT. FOLLOWING STERILIZATION, UNITS ARE 200% INSPECTED FOR PARTICULATE IN THE SOLUTION AND THEN PACKAGED INTO POUCHES AND SEALED. THE PRODUCT INSERT INCLUDES THE FOLLOWING INSTRUCTIONS: 1) OUTSIDE THE STERILE FIELD, REMOVE THE PRODUCT VIAL FROM THE CLEAR POLYETHYLENE BAG AND PLACE IT IN A STABLE LOCATION. DO NOT SHAKE THE PRODUCT. 2) HOLD THE PRODUCT VIAL FIRMLY, AND REMOVE THE ALUMINUM SEAL AND STOPPER. 3) WITHIN THE STERILE FIELD, SECURELY PLACE A 20 GAUGE CANNULA ON A 10 ML SYRINGE 4) HOLD THE VIAL WITHIN REACH OF THE STERILE FIELD AND ASEPTICALLY INTRODUCE THE CANNULA FITTED INTO THE SYRINGE INTO THE VIAL AND WITHDRAW THE PRODUCT TAKING CARE NOT TO INTRODUCE AIR BUBBLES. TWO PERSONS ARE REQUIRED FOR THIS PROCEDURE. 5) AFTER THE PRODUCT HAS BEEN COMPLETELY TRANSFERRED INTO THE SYRINGE REMOVE THE 20 GAUGE CANNULA FROM THE SYRINGE AND DISPOSE OF IT PROPERLY. SECURELY PLACE A NEW STERILE CANNULA ONTO THE SYRINGE. 6) THE PRODUCT IS NOW READY TO BE USED. THE SYRINGE MAY BE STORED TEMPORARILY WITHIN THE CANNULA POINTED UPWARD TO ALLOW ANY AIR BUBBLES TO COME TO THE TIP FOR EASY REMOVAL. 7) AT THE CONCLUSION OF THE PROCEDURE PROPERLY DISCARD THE SYRINGE AND ANY REMAINING PRODUCT. THE ROOT CAUSE OF COMPLAINT CONDITION COULD NOT BE DETERMINED. POTENTIAL ROOT CAUSE INCLUDES: SOLUTION QUALITY ISSUE ¿ HIGHLY UNLIKELY, AS CHEMISTRY AND MICROBIOLOGY DATA IS REVIEWED AND VERIFIED TO MEET REGULATORY REQUIREMENTS PRIOR TO RELEASE. CONSUMER MISHANDLING - NO CONCLUSION CAN BE MADE REGARDING THE CONTRIBUTION OF CONSUMER MISHANDLING AS THIS FACTOR IS OUTSIDE THE CONTROL OF THE MANUFACTURING FACILITY. EVENT OUTSIDE OF MANUFACTURER'S CONTROL (PRODUCT STORAGE, USE, AND SURGICAL PRACTICE); THIS COULD NOT BE CONFIRMED. THE PRODUCT LABELING PROVIDES INDICATIONS FOR USE, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, AND DIRECTIONS FOR USE TO ENSURE PROPER USE OF THE PRODUCT. SURGICAL TECHNIQUE, PRODUCT HANDLING AND STORAGE ARE UNKNOWN. LOT SPECIFIC EVALUATION IS NOT POSSIBLE WITHOUT THE LOT CODE BEING REPORTED. NO FURTHER ACTION WARRANTED AT THIS TIME. THE MANUFACTURER WILL CONTINUE TO MONITOR DATA FOR EVIDENCE OF ADVERSE TRENDING AND TAKE FURTHER ACTION, AS APPROPRIATE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
A CUSTOMER REPORTED THAT AN OPHTHALMIC SILICONE OIL WAS PLACED SUCCESSFULLY IN A PATIENT'S EYE FOR REPAIR OF RETINAL RUPTURE. POST-OPERATIVELY WITHIN A YEAR, THE EMULSIFICATION BUBBLES FILLED FRONT HALF OF EYE THAT CAUSED OCCLUSION OF VISION. THE SILICONE OIL WAS REMOVED BY USING AN UNSPECIFIED MEDICAL/SURGICAL INTERVENTION. THE CURRENT PATIENT CONDITION WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.
ADDITIONAL INFORMATION HAS BEEN RECEIVED INDICATING THAT THE PATIENT HAD MULTIPLE POST-OPERATIVE VISITS WITH THE LAST ONE BEING FOR INCREASED FLOATERS AND VISUAL DISTORTION. THE CURRENT PATIENT CONDITION WAS NOT PROVIDED.
ADDITIONAL INFORMATION HAS BEEN RECEIVED INDICATING THAT THE PATIENT HAD MULTIPLE POST-OPERATIVE VISITS WITH THE LAST ONE BEING FOR INCREASED FLOATERS AND VISUAL DISTORTION. THE CURRENT PATIENT CONDITION WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1517969 | SILIKON 1000 OIL | FLUID, INTRAOCULAR | LWL | ALCON RESEARCH, LLC | NA | ASKU | 00380656011873 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Unknown | Required Intervention |