MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC WHITESTAR SIGNATURE; UNIT, PHACOFRAGMENTATION

Model Number NGP680300

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

Patient Problems Macular Edema (1822); Retinal Detachment (2047)

Event Type  Injury  

Manufacturer Narrative

Section b3: date of event: exact dates not provided.Article acceptance date is august 8, 2020 section h3-other (81): the device was not returned for analysis.The serial number for this 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.Citation: burridge, s.; kazakos, d.; asaria, r.; unilateral acute macular edema with serous macular detachment after bilateral phacoemulsification; copyright © 2021 published by wolters kluwer on behalf of ascrs and escrs; https://doi.Org/10.1097/j.Jcro.0000000000000043.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

The following article was received based on a literature review: article: unilateral acute macular edema with serous macular detachment after bilateral phacoemulsification.Two case reports were done to present 2 cases of unilateral serous macular detachment and intraretinal fluid accumulation that occurred 1 day after otherwise uneventful bilateral phacoemulsification procedures.A 68-year-old man (case 1) and a 53-year-old man (case 2) both underwent bilateral refractive lens exchange with hydrophobic acrylic intraocular lens implantation.Sequential bilateral phacoemulsification was done on both patients using the whitestar signature phacoemulsification system with fusion fluidics (abbott medical optics, inc.).On postoperative day 1, eye examination and optical coherence tomography (oct) on both cases confirmed serious macular detachment with significant intraretinal fluid accumulation in the left eye.In case 1, the serous macular detachment with intraretinal fluid accumulation was completely resolved on postoperative day 3 with no additional treatment while in case 2, topical nepafenac 0.1% three times daily was added to topical steroid and antibiotic therapy and completely resolved by postoperative day 8.No further details were provided.This report is for patient # 1 reported.

• Brand Name: WHITESTAR SIGNATURE
• 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: 17456074
• MDR Text Key: 320378146
• Report Number: 3012236936-2023-01938
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K060366
• 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: 08/03/2023

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: NGP680300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/12/2023
• Initial Date FDA Received: 08/03/2023
• 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
• Patient Age: 68 YR
• Patient Sex: Male