MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC UNK_PHACO MACHINE_WHITESTAR SIGNATURE SYSTEM; UNIT, PHACOFRAGMENTATION

Model Number NGP680300

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

Patient Problems Dry Eye(s) (1814); Visual Disturbances (2140); Halo (2227)

Event Date 12/14/2021

Event Type  Injury  

Manufacturer Narrative

Section a - patient demographics: several attempts to collect information regarding patient demographics have been made but at the time of this report no information has been provided.There is a summary of the age and the gender of the patients involved in the study and it has been provided below.Age at surgery - 66 ± 9 yrs.Male - 60 patients.Female - 95 patients.(b)(4).Device evaluation: the device was not returned for evaluation.Since serial number is unknown a manufacturer record review related to the device including device history record could not be performed.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.Citation: 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.

Event Description

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 whitestar signature system used for the standard phacoemulsification cataract procedure, model unknown.Separate reports are being submitted for the other listed devices.

• Brand Name: UNK_PHACO MACHINE_WHITESTAR SIGNATURE SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• 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: 15255858
• MDR Text Key: 298199665
• Report Number: 3012236936-2022-02222
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NGP680300
• Device Catalogue Number: WHITESTAR SIGNATURE SYSTEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/21/2022
• Initial Date FDA Received: 08/18/2022
• 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