MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC CATALYS SYSTEM; OPHTHALMIC FEMTOSECOND LASER

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Corneal Edema (1791); Macular Edema (1822); Intraocular Pressure Increased (1937); Retinal Detachment (2047); Uveitis (2122); Blurred Vision (2137); Visual Impairment (2138); Vitreous Loss (2142); Vitreous Hemorrhage (2143); Prolapse (2475); Capsular Bag Tear (2639); Zonular Dehiscence (2698); Toxic Anterior Segment Syndrome (TASS) (4469); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Section a2: 56.95 ± 7.99 (30, 83) section a3: males 50.6%, females 49.4% section h3-other (81): the device was not returned for analysis.The serial number for the device is not available; therefore, no further investigation can be performed.If there is any further relevant information received, a supplemental medwatch will be filed.Section h6 -health effect - clinical code: 4581: no code available for device decentered or dislocated or tilted subluxated or wrong position.Citation: hannan sj, schallhorn sc, venter ja, teenan d, schallhorn jm, immediate sequential bilateral surgery in refractive lens exchange patients: clinical outcomes and adverse events, ophthalmology (2023), doi: https://doi.Org/10.1016/j.Ophtha.2023.04.013.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It is unclear from the article which lens models correspond to the reported patient issues and interventions.There is no clear indication that johnson & johnson devices caused or contributed to the reported incidents.However, as a causal link cannot be discounted, the following report is being submitted for the stated product family.The following article was received based on a literature review: article: immediate sequential bilateral surgery in refractive lens exchange patients: clinical outcomes and adverse events a retrospective case series was done to evaluate outcomes and the incidence of adverse events in patients who underwent immediate sequential bilateral cataract surgery (isbcs) same-day refractive lens exchange (rle).A total of 17,330 patients (n=34,660 eyes) were included.Of these, patients received multifocal intraocular lens (iol) (n=28,827 eyes), and monofocal iol (n=5,833 eyes).Multifocal iols included: tecnis +2.75 add zkb00 (n=18,895), lenstec sbl (n=4,444), tecnis symfony toric zxt (n=1,863), tecnis symfony zxr00 (n=1,729), tecnis +3.25 add zlb00 (n=872), at lara 829mp (n=616), and, other lenses implanted in less than 500 eyes per model (n=408).Monofocal iols included tecnis zcb00 (n= 3,395), tecnis toric zct (n=1,068), tecnis pcb00 (n=611), and other lenses implanted in less than 500 eyes per model (n=759).Prior to intraocular surgery, all patients underwent full ophthalmic examination and diagnostic scans which included wavefront aberration measurement (idesign advanced wavescan system, johnson & johnson vision care, inc, santa ana, ca).Surgeries were performed either with the assistance of a femtosecond laser (catalys precision laser system, johnson & johnson vision care, inc, santa ana, ca) or with standard phacoemulsification.Intraoperative events included: posterior capsule tear without vitreous loss (n=20) posterior capsule tear with vitreous loss (n=13) posterior capsule tear with dropped nucleus or lens material in the vitreous (n=4) zonule dialysis (n=4) zonule rupture with vitreous loss (n=1) iris prolapse during surgery (n=2) irrigation misdirection (n=5) intraoperative iol complications (e.G., torn iol, broken haptics, etc.) (n=3) incorrect iol power (noted and resolved on the day of surgery) (n=1) surgical equipment failure (n=2) serious postoperative adverse events within the first month were: cystoid macular edema (diagnosed with optical coherence tomography within the first postoperative month, reducing corrected distance visual acuity (cdva) by more than 2 snellen lines compared to preoperative cdva) (n=172) corneal edema (surgery-related corneal edema persisting for longer than 1 month postoperatively) (n=28) persistent inflammation (anterior uveitis persisting for longer than 4 weeks) (n=27) significantly raised intraocular pressure (iop) (n=27) toxic anterior segment syndrome (tass) (n=8) wound leak (n=3) retinal detachment (n=1) retinal tear (n=1) secondary surgical interventions included: rotation of a misaligned toric iol (n=24) exchange of iol due to incorrect lens power (n=6) removal of retained lens material/cortical clear-up (n=5) repositioning of a displaced iol (n=4) exchange of a displaced iol (n=3) vitrectomy for nucleus/lens material dropped into the vitreous (n=4) removal of vitreous strand from anterior chamber/corneal wound (n=3) removal of retained ophthalmic viscoelastic device (n=2) exchange of iol due to near vision complaints (from monofocal to multifocal) (n=1) pars plana vitrectomy for vitreous hemorrhage following posterior capsule tear event (n=1) implantation of iris fixated iol following posterior capsule tear event (n=1) retinal detachment repair (n=1) retinal tear repair (n=1) it is unclear however, if it was our device or the other devices in the study that was implanted and used in the eyes which had all these events.There were no further interventions reported.A copy of an extract from the article is provided with this report.

• Brand Name: CATALYS SYSTEM
• Type of Device: OPHTHALMIC FEMTOSECOND LASER
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 17477325
• MDR Text Key: 320632468
• Report Number: 3012236936-2023-02031
• Device Sequence Number: 1
• Product Code: OOE
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K113479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNK-CATALYS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention