MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC WHITESTAR SIGNATURE CONSOLE; PHACOEMULSIFICATION SYSTEM

Model Number NGP680300

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

Patient Problems Endophthalmitis (1835); Hemorrhage/Bleeding (1888); Retinal Detachment (2047); Vitreous Loss (2142); Capsular Bag Tear (2639); Zonular Dehiscence (2698); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/05/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4): 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.Citation: vazquez-ferreiro, p., carrera-hueso, f.J., barreiro-rodriguez, l., diaz-rey, m., & jornet, j.E.(2019).Prevalence of cataract complications in patients with pseudoexfoliation syndrome in northwestern spain.Arquivos brasileiros de oftalmologia, 82(6).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: prevalence of cataract complications in patients with pseudoexfoliation syndrome in northwestern spain.A retrospective cohort study was done to assess the relationship between pseudoexfoliation syndrome (pes) and the incidence of complications and its related clinical factors in patients undergoing cataract surgery.A total of 681 eyes of 503 patients underwent cataract surgery and were divided into two groups: patients with pes (n=120 eyes of 106 patients; pes group) and patients with no pes (n= 561 eyes of 487 patients; non-pes group).All patient underwent bimanual phacoemulsification with a temporal 2.75-mm limbal incision using the divide and conquer approach with the whitestar signature phaco machine (advanced medical optics, inc.).In the pes group, intraoperative complications include posterior capsular rupture (n=6), vitreous loss (n=2), zonular dialysis (n=7), and intraoperative miosis (n=13) in the non-pes group, intraoperative complications include posterior capsular rupture (n=28), vitreous loss (n=11), zonular dialysis (n=5), and intraoperative miosis (n=30) while early postoperative complications (within 1 year) include retinal detachment (n=8), suprachoroidal hemorrhage (n=2), and endophthalmitis (n=3).There are no indications in the article of any interventions provided.

• Brand Name: WHITESTAR SIGNATURE CONSOLE
• Type of Device: PHACOEMULSIFICATION SYSTEM
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: somyata nagpal ; 510 cottonwood drive; milpitas, CA 95035 ; 7142478552
• MDR Report Key: 12234822
• MDR Text Key: 264695776
• Report Number: 3006695864-2021-08139
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K060366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• 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: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/30/2021
• 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): Other