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 Wrinkling (2613); Toxic Anterior Segment Syndrome (TASS) (4469)

Event Type  Injury  

Manufacturer Narrative

Weight and ethnicity: unknown, not provided.Date of event is unknown.Best estimated dates are from march 2021 thru april 2021.Serial number is unknown as it was not provided.Unique identifier (udi) number unknown as serial number was not provided.Concomitant medical products: lens model dib00u0190 sn: (b)(4) -right eye and lens model dib00u0190 sn: (b)(4)-left eye.Manufacturer date is unknown as serial number was not provided.Although several attempts were made, the clinic is reporting this adverse event only and did not request or require field service or clinical support.A review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that several patients developed post-op complications after the implantation of dcboo and or diboo intraocular lenses with the use of the signature pro equipment.The date of surgeries was between january and april of 2021.The post op complications reported were edema with various grades, fibrin, cells graded from trace to 3+, folds with increase, and retinal hemorrhage.This report is for the following: a (b)(6) year-old woman developed folds 1+ after cataract extraction on both eyes with intraocular lens with model diboo-tecnis simplicity with the use of the signature pro equipment.Although several attempts were made, no additional information was provided.

Manufacturer Narrative

Additional information: section b5: through follow up, it was determined the patient experienced toxic anterior segment syndrome (tass).Section h6-health effect clinical code 4469 - toxic anterior segment syndrome (tass).Device evaluation: a johnson & johnson representative visited the site location.After discussions with the treating surgeon, the surgeon comments t are that believes this event is a sterilization issue with some of surgery center¿s instruments etc.The j&j representative reviewed the directions for use (dfu) of how to sterilize the handpieces with the administration of the operating room (or), staff, and surgeon.At this time, no further occurrences have been reported.As stated in initial report, a review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.All pertinent information available to johnson & 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
• MDR Report Key: 11999203
• MDR Text Key: 256195149
• Report Number: 3006695864-2021-07919
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Public: (01)
• Combination Product (y/n): N
• PMA/PMN Number: K151636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NGP680301
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR