TECNIS IOL
Report
- Report Number
- 3012236936-2022-02178
- Event Type
- Injury
- Date Received
- August 16, 2022
- Date of Event
- December 14, 2021
- Report Date
- August 15, 2022
- Manufacturer
- AMO PUERTO RICO MFG. INC.
- Product Code
- MJP
- PMA / PMN Number
- P980040
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
AGE/DATE OF BIRTH: GROUP PCS: 66 ± 9[37¿86] AND GROUP FLACS: 68 ± 9 [41¿89] (YEARS). SEX/GENDER: GROUP PCS: MALE: 60 (38.7), FEMALE: 95 (61.3). GROUP FLACS: MALE: 66 (46.2), FEMALE: 77 (53.8). DATE OF EVENT: (B)(6) 2021 (THE DATE ARTICLE WAS PUBLISHED). (B)(4). MOSHIRFAR M., WAITE AJ., ELLIS JH., HUYNH R., PLACIDE J., BARKE MR., MCCABE SE., RONQUILLO YC., HOOPES PC JR., BRADLEY MJ., HOOPES PC. (2021). A ONE YEAR LONGITUDINAL COMPARATIVE ANALYSIS OF VISUAL OUTCOMES BETWEEN FEMTOSECOND LASER-ASSISTED CATARACT SURGERY AND STANDARD PHACOEMULSIFICATION CATARACT SURGERY. CLIN OPHTHALMOL. 15(1), PP. 4667-4680. AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, NO DEFINITIVE RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.
THE FOLLOWING ARTICLE WAS RECEIVED BASED ON LITERATURE REVIEW. ARTICLE: A ONE YEAR LONGITUDINAL COMPARATIVE ANALYSIS OF VISUAL OUTCOMES BETWEEN FEMTOSECOND LASER-ASSISTED CATARACT SURGERY AND STANDARD PHACOEMULSIFICATION CATARACT. A RETROSPECTIVE, SINGLE-CENTER COMPARATIVE STUDY WAS DONE TO ASSESS VISUAL OUTCOMES OVER TIME OF FEMTOSECOND LASER-ASSISTED CATARACT SURGERY (FLACS) COMPARED TO STANDARD PHACOEMULSIFICATION CATARACT SURGERY (PCS). A TOTAL OF 298 EYES WERE DIVIDED TO PCS GROUP (N=155EYES) AND FLACS GROUP (N=143 EYES) AND WERE ANALYZED AT 1 WEEK, 3 MONTHS, AND 1 YEAR. PATIENTS UNDERGOING FLACS WERE TREATED WITH THE CATALYS FEMTOSECOND LASER SYSTEM (PRECISION LENS, BLOOMINGTON, MN). PHACOEMULSIFICATION WAS PERFORMED IN A DIVIDE-AND- CONQUER FASHION USING THE WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM (ADVANCED MEDICAL OPTICS INC, INC. SANTA ANA, CA). IMPLANTED INTRAOCULAR LENSES (IOLS) WERE EITHER TORIC OR NON-TORIC. AMONG THESE INCLUDED IOLS FROM THE TECNIS PLATFORM (JOHNSON & JOHNSON) AND AMO (ABBOTT MEDICAL OPTICS): ZCB00, TECNIS MONOFOCAL 1-PIECE IOL (PCS [N=26 EYES]; FLACS [N=22 EYES]); ZA, TECNIS MONOFOCAL 3-PIECE IOL (FLACS [N=2 EYES]); ZCT/ZCU, TECNIS TORIC II IOL (PCS [N=21 EYES]; FLACS [N=26 EYES]); ZKU, TECNIS MULTIFOCAL TORIC II IOL (FLACS [N=3 EYES]); ZMA, TECNIS MULTIFOCAL IOL (PCS [N=1 EYE]); ZXR00, TECNIS SYMFONY IOL (PCS [N=5 EYES]; FLACS [N=2 EYES]); ZXT, AMO SYMFONY TORIC IOL (PCS [N=30 EYES]; FLACS [N=29 EYES]). THERE WERE OTHER IOLS USED FROM OTHER MANUFACTURERS. COMPLICATIONS INCLUDED: POSTOPERATIVE LOSS OF 1 LINE (CHANGE IN SNELLEN BDVA): PSC GROUP = 10% (N=5 EYES); FLACS GROUP = 2% (N=1 EYE). AT 3 MONTHS POSTOPERATIVE: GLARE: FLACS (N=1 EYE), HALO: PCS (N=3 EYES); FLACS (N=8 EYES), PHOTOPHOBIA: PCS (N=2 EYES), DRY EYES: PCS (N=6 EYES); FLACS (N=13 EYES), NIGHT VISION ISSUES: PCS (N=6 EYES); FLACS (N=3 EYES). AT 1 YEAR POSTOPERATIVE: DRY EYES: PCS (N=5 EYES); FLACS (N=11 EYES). POSTOPERATIVE PROCEDURES INCLUDED: YAG LASER CAPSULOTOMY (= 3 MONTHS POST-OP): PCS (N=1 EYE): FLACS (N=1 EYE). YAG LASER CAPSULOTOMY (= 1-YEAR POST-OP): PCS (N=5 EYES); FLACS (N=8 EYES). LIMBAL RELAXING INCISIONS: FLACS = (N=6 EYES). IT IS UNCLEAR HOWEVER, IF IT WERE OUR DEVICES OR THE OTHER DEVICES IN THE STUDY THAT WERE USED OR IMPLANTED IN THE EYE THAT CAUSED THESE EVENTS. THERE WERE NO FURTHER INTERVENTIONS REPORTED. THIS REPORT IS FOR THE INTRAOCULAR LENS, MODEL ZCT. SEPARATE REPORTS ARE BEING SUBMITTED FOR THE OTHER LISTED MODELS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1509384 | TECNIS IOL | LENS, INTRAOCULAR, TORIC OPTICS | MJP | AMO PUERTO RICO MFG. INC. | UNK_ZCT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |