MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS SIMPLICITY; INTRAOCULAR LENS

Model Number DCB00V

Device Problems Inaccurate Delivery (2339); Physical Resistance/Sticking (4012)

Patient Problems Hyphema (1911); Eye Pain (4467)

Event Type  malfunction  

Event Description

It was reported that bleeding had been observed in a patient¿s eye after the patient's complaining of pain during implantation of dcb00v.Bleeding was absorbed with irrigation/aspiration (ia), and the procedure was completed without problems.No haptics had been stretched out.However, it was noted that intraocular lens (iol) had unstably come out from its cartridge.The physician considered it could be lens-induced problem from the timing of bleeding.Nevertheless, there was no patient post-op injury.Through follow-up it was confirmed that the iol remains implanted.There was no incision enlargement, no vitrectomy and no sutures required.The patient outcome is good, vision intact.There was adhesion between two haptics of the lens.The doctor concluded that they do not consider the event to be an intraocular injury or intraocular bleeding.When the chip was advanced into the eye with ia, blood bubbled up in all cases, so doctor felt that it was bleeding from the inside of the eye.It is highly probable that the bleeding that occurred in the eye entered the eye and appeared to be bleeding.It was confirmed that there is no effect on eyesight.There was no cartridge tip damage reported.It was noted that the device was prepared and used accordingly with enough amount of ocular viscoelastic agent/healon and there was no resistance felt during extrusion of the lens.No other information was provided.This report captures the first event.Separate reports are being submitted for the addition two events.

Manufacturer Narrative

Date of event: the exact date is unknown, the best estimate is prior to (b)(6) 2022.If explanted, give date: not applicable as lens remains implanted.Reporter phone number: (b)(6).This report is being filed on an international device; tecnis optiblue simplicity preloaded 1-piece iol, model dcb00v that has a similar device, tecnis simplicity preloaded 1-piece iol model dcb00 which is distributed in the unites states under pma p980040.The device was not returned for evaluation as it remains implanted; therefore, a failure analysis of the complaint device cannot be completed.As the serial number of the device is unknown no further investigation can be performed.If there is any relevant information received, a supplemental medwatch will be filed.Device manufacture date: unknown, as the serial number was not provided.An attempt has been made to obtain missing information; however, the information has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Corrected data: upon further review, per new information received it was noted by the doctor that the bleeding was probably not bleeding from the eye.The doctor determined that there was a high possibility that the blood flowed into the eye when the conjunctiva was incised and the blood returned to the eye.He doesn't consider it to be an intraocular injury or intraocular bleeding.He clarified that when the chip was advanced into the eye with irrigation/aspiration, blood bubbled up in all cases, so doctor felt that it was bleeding from the inside of the eye.It is highly probable that the bleeding that occurred in the eye entered and appeared to be bleeding.Since there is no effect on eyesight, jjsv complaint investigation is unnecessary for this event of bleeding.Therefore, there was no allegation on suspect product about the bleeding.Hence, "hyphema" was not indicated as a patient code.Therefore, this "code: 1911: hyphema" is being removed from section h6: health effect clinical code, as indicated in the initial report submitted.This report is being submitted to correct this info.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Corrected data: in review, because of new information excluding "hyphema" as a patient code, it is determined that only a malfunction occurred in this event and no serious injury.Therefore, this correction is submitted to correct this error.Fields below are updated: section b1: report type: product problem.Section h1: type of reportable event: malfunction.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SIMPLICITY
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 15629875
• MDR Text Key: 301979697
• Report Number: 3012236936-2022-02549
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DCB00V
• Device Catalogue Number: UNK-DCB00V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: HEALON, MODEL AND LOT UNKNOWN
• Patient Outcome(s): Other
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian