TECNIS SYMFONY TORIC
Report
- Report Number
- 9614546-2019-00840
- Event Type
- Injury
- Date Received
- September 9, 2019
- Date of Event
- May 30, 2019
- Report Date
- November 12, 2020
- Manufacturer
- JOHNSON & JOHNSON SURGICAL VISION, INC.
- Product Code
- MFK
- UDI-DI
- 05050474605237
- PMA / PMN Number
- P980040
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
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 (B)(4) AND CAPA-010215.
ADDITIONAL INFORMATION: ADDITIONAL INFORMATION WAS RECEIVED FOR THE SUBJECT'S 1-YEAR VISIT. AT ONE-YEAR, THE SUBJECT'S MONOCULAR UNDERCORRECTED DISTANCE VISUAL ACUITY (UCDVA): 20/25 OD, 20/20 OS; BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA): 20/20 OD, 20/20 OS. THE SUBJECT REPORTED BEING EXTREMELY BOTHERED BY HALOS (NIGHT TIME AROUND ANY LIGHT IN OR OUTSIDE), EXTREMELY BOTHERED BY STARBURSTS (NIGHT TIME DRIVING AND GENERAL LIGHTING AT NIGHT), EXTREMELY BOTHERED BY MULTIPLE OR DOUBLE VISION (FOCUSING), EXTREMELY BOTHERED BY SENSITIVITY TO LIGHT (HEADLIGHTS/DRIVING), EXTREMELY BOTHERED BY GLARE RELATED TO SCATTERED LIGHT (NIGHT DRIVING), EXTREMELY BOTHERED BY POOR LOW LIGHT VISION (TRYING TO FOCUS). BASED ON THE ADDITIONAL INFORMATION RECEIVED ADDITIONAL PATIENT 3191-DIPLOPIA IS BEING PROVIDED. NO SURGICAL INTERVENTION IS PLANNED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.
IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THE DEVICE REMAINS IMPLANTED. (B)(4). DEVICE EVALUATION: THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURING SITE. THEREFORE, PRODUCT TESTING COULD NOT BE PERFORMED AND THE CUSTOMER¿S REPORTED COMPLAINT COULD NOT BE VERIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WAS REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH ON COMPLAINTS REVEALED THAT NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FOR THIS PRODUCTION ORDER NUMBER. AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.
IT WAS REPORTED THAT A PATIENT IS INCLUDED IN A CLINICAL STUDY OF LENSES. THE PATIENT WAS IMPLANTED A BILATERAL ZXT150 INTRAOCULAR LENS (IOL). IT WAS LEARNT THAT AT ABOUT THE 6TH MONTH OF FOLLOW-UP, THE SUBJECT NOTED: VERY BOTHERED BY HALOS: DIFFICULT TO SEE CLEARLY WHEN HEADLIGHTS ARE FACING TOWARD ME/ALSO HAVE HALOS IN MY HOME AROUND LIGHT SOURCES LIKE CLOCK RADIO LIGHT. VERY BOTHERED BY STARBURSTS: SEEING CLEARLY WHEN HEADLIGHTS ARE COMING AT ME AT NIGHT. VERY BOTHERED BY GLARE RELATED TO SCATTERED LIGHT: VERY BOTHERED ON A TWO LANE ROAD. MODERATELY BOTHERED BY POOR LOW LIGHT VISION: READING MENUS OR SMALL PRINT THE SYMPTOMS DO INTERFERE WITH DAILY ACTIVITIES. THE IOLS STILL REMAIN IMPLANTED IN THE SUBJECT IN BOTH EYES WITH NO INTERVENTION PLANNED. PRE-OPERATIVE BEST CORRECTED VISUAL ACUITY (BCVA): RIGHT EYE (OD) 20/40 LEFT EYE (OS) 20/50 6 MONTH BCVA OD 20/20 OS 20/20. NO OTHER INFORMATION WAS PROVIDED. THIS MDR REPORT PERTAINS TO THE LEFT EYE (OS). A SEPARATE REPORT WILL BE SUBMITTED FOR THE RIGHT EYE (OD).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 769444 | TECNIS SYMFONY TORIC | MULTIFOCAL IOLS | MFK | JOHNSON & JOHNSON SURGICAL VISION, INC. | ZXT150 | 05050474605237 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |