COMPACT INTUITIV PACK DISPOSABLE TUBING SET
Report
- Report Number
- 3006695864-2020-00311
- Event Type
- Injury
- Date Received
- July 6, 2020
- Date of Event
- June 3, 2020
- Report Date
- October 29, 2020
- Manufacturer
- JOHNSON & JOHNSON SURGICAL VISION, INC.
- Product Code
- HQC
- PMA / PMN Number
- K060366
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
SECTION D10. DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: 7/01/2020. SECTION H3. DEVICE RETURNED TO MANUFACTURER? YES. DEVICE EVALUATION: THE OPO80 TUBING PACK WAS AS RECEIVED WITHOUT ITS TYVEK LID, AND LOT# CANNOT BE OBTAINED. A VISUAL INSPECTION OF THE RETURNED PRODUCT DID NOT REVEAL ANY DEBRIS, LOOSE PARTICLES, FIBERS OR DAMAGE/DEFECTS. ALL FUNCTIONAL TESTS WERE PERFORMED, AND RESULTS WERE FOUND WITHIN SPECIFICATIONS. THE RETURNED PACK FUNCTIONED AS INTENDED. THE REPORTED ISSUE COULD NOT BE CONFIRMED. A VIDEO OF THE REPORTED ISSUE WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION MEDICAL AFFAIR FOR REVIEW. PER MEDICAL AFFAIR TEAM, ¿THE WHITENING (WHITENING CIRCULAR PATTERN) OBSERVED IN THE MAIN WOUND THAT APPEARED AFTER THE PHACO PROCEDURE WAS STARTED, SEEMS TO BE COMPATIBLE WITH A WOUND THERMAL INJURY. THE EDEMA SEEMS TO BE MORE ASSOCIATED TO THE MULTIPLE ATTEMPTS TO CLOSE THE INCISION THROUGH STROMAL HYDRATION PRIOR TO THE CORNEAL SUTURE. SINCE THE OBSERVATION (THERMAL INJURY) WAS LOCATED WHERE THE PHACO PROBE ENTERED THE EYE ANTERIOR CHAMBER, THE MOST PROBABLE CAUSE OF THE ISSUE WAS AN OVERHEATING OF THE PROBE TIP. SUCH OBSERVATION MAY BE ASSOCIATED TO AN INSUFFICIENT OR UNBALANCED IRRIGATION ASPIRATION, EITHER INSUFFICIENT OR UNBALANCED IRRIGATION ASPIRATION MAY BE MULTIFACTORIAL.¿ RETURN PHACO PACK OPO80 WAS TESTED FOR IRRIGATION FLOW RATE, ASPIRATION FLOW RATE, AND ALSO VACUUM, HOWEVER, ALL RESULTS WERE FOUND WITHIN SPECIFICATIONS. BASED ON THE INFORMATION OBTAINED, PRODUCT MALFUNCTION CANNOT BE CONFIRMED. MANUFACTURING RECORD REVIEW: THE OPO80, LOT# WAS NOT PROVIDED AND CANNOT BE OBTAINED BASED ON REPORTED INFORMATION. THEREFORE, MANUFACTURER RECORD REVIEW AND COMPLAINT HISTORY REVIEW CANNOT BE PERFORMED. CONCLUSION: BASED ON THE INVESTIGATION RESULTS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. JOHNSON & JOHNSON SURGICAL VISION WILL CONTINUE TO MONITOR THIS TYPE OF COMPLAINTS. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED. H3 OTHER TEXT : PLACEHOLDER.
THIS CORRECTION MDR IS BEING SUBMITTED TO ADDRESS INACCURATE INFORMATION IN SECTION F ON THE XML VERSION OF THE PREVIOUS SUBMISSION CAUSED BY A SOFTWARE GLITCH IN THE TRANSMISSION PROCESS. THE INTERNAL NON-CONFORMANCE NUMBERS FOR THIS SOFTWARE ISSUE ARE NR-0148919 AND CAPA-010215.
LOT NO. IS UNKNOWN AS IT WAS NOT PROVIDED. UNIQUE IDENTIFIER (UDI #) IS UNKNOWN AS LOT NO. WAS NOT PROVIDED (B)(6). MANUFACTURER DATE IS UNKNOWN AS LOT NO WAS NOT PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.
DURING A CATARACT EXTRACTION PROCEDURE, A THERMAL BURN AND EDEMA OCCURRED IN THE PATIENT¿S OPERATIVE EYE WHEN USING THE OPO80- COMPACT INTUITIV PACK DISPOSABLE TUBING SET. A BRIEF DESCRIPTION FROM THE SURGERY CENTER INDICATED THE PHACO TIP WAS INSERTED INTO PATIENT¿S EYE AND APPLIED, LOTS OF BUBBLES EXPELLED. ONE SIDE OF IRRIGATION SEEMED NOT FLOWING, AND SLIGHT THERMAL BURN OCCURRED. THE WOUND WAS SUTURED TO CLOSE. THE PROCEDURE WAS DELAYED FOR APPROXIMATELY 20 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 696938 | COMPACT INTUITIV PACK DISPOSABLE TUBING SET | PHACO TUBING | HQC | JOHNSON & JOHNSON SURGICAL VISION, INC. | OPO80 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | TIP, HANDPIECE| TIP, HANDPIECE |