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

Model Number NGP680301

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

Patient Problems Glaucoma (1875); Hyphema (1911); Intraocular Pressure Increased (1937)

Event Type  Injury  

Manufacturer Narrative

Section a2: mean age 71.6 +- 10.5.Section a3: 14 female and 13 male patients.Section b3: date of event: exact dates not provided.Article acceptance date is january 8, 2023.The study was conducted for surgeries performed between december 2016 and december 2020.Section d4: serial number: unknown, information not provided.Section d4: expiration date: unknown, as the serial number was not provided.Section d4: udi number: unknown, as the serial number was not provided.Section h3 - other (81): the machine was not returned for evaluation.Therefore, a failure analysis of the complaint device could not be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review and possible product return and evaluation, if there is any further relevant information a supplemental medwatch will be filed.Section h4: device manufacture date: unknown, as the serial number was not provided.Citation: okada, n.; hirooka, k.; onoe, h.; okumichi, h.; kiuchi, y.Comparison of mid-term outcomes between microhook ab interno trabeculotomy and goniotomy with the kahook dual blade.J.Clin.Med.2023, 12, 558.Https://doi.Org/10.3390/jcm12020558.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: comparison of mid-term outcomes between microhook ab interno trabeculotomy and goniotomy with the kahook dual blade a retrospective study was done to compare the mid-term surgical outcomes between patients who underwent phacoemulsification in primary open-angle glaucoma (poag) and exfoliation glaucoma combined with microhook ab interno trabeculotomy (lot) and goniotomy with the kahook dual blade (kdb).A total of 54 eyes underwent either microhook ab interno trabeculotomy (lot) (n=27 eyes) or goniotomy with the kahook dual blade (n=27 eyes).Phacoemulsification in all eyes was performed using the signature pro (johnson & johnson) and the intraocular lens (iol) implanted were either the pcb00v (johnson & johnson) or the xy1 (hoya) iol.In order to increase the visuality of schlemm¿s canal after the cataract surgery, sufficient sodium hyaluronate (healon; johnson & johnson vision) was added to the anterior chamber.Postoperative complications include transient iop elevation (n=5) and hyphema with niveau (n=4).The hyphema disappeared within 2 weeks in all of the cases.It was reported that additional surgery was required in 3 eyes in the kdb-phaco group, with one surgery for exfoliation glaucoma and the other two surgeries for primary open angle glaucoma (poag) all of which were due to inadequate iop reduction (>21 mmhg).No further details were provided.Separate reports will be submitted for the other two johnson & johnson devices reported.

Manufacturer Narrative

Corrected information: based on a further review of the information received, the code 1875 (glaucoma) was removed and the code 4625 (additional surgery) was added.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: WHITESTAR SIGNATURE PRO
• 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: 17455524
• MDR Text Key: 320380604
• Report Number: 3012236936-2023-01914
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K151636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/20/2023

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: NGP680301
• Device Catalogue Number: NGP680301
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/03/2023
• Supplement Dates Manufacturer Received: 10/27/2023
• Supplement Dates FDA Received: 11/20/2023
• 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