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

Model Number PCB00

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

Patient Problems Corneal Edema (1791); Endophthalmitis (1835); Inflammation (1932); Blurred Vision (2137); Eye Pain (4467)

Event Date 11/08/2021

Event Type  Injury  

Manufacturer Narrative

Age,weight and ethnicity: unknown/ not provided.If explanted, give date: not applicable as the lens remains implanted.(b)(6).The device is not returning for evaluation as to date it remains implanted; therefore, a failure analysis of the complaint device cannot 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, if there is any further relevant information 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 a patient was implanted with a tecnis intraocular lens (iol) in both eyes and developed endophthalmitis several days or a week post implantation.Patient vision was good at day-1 post op visit, but later developed sore eyes and blurred vision on examination, endophthalmitis inflamed and corneal edema.The patient was treated with anti-viral and antibiotic medication and was resolved over a couple of weeks.There were no other interventions or delay in the surgery reported.The patient was reported to be temporarily impaired.It was indicated that the surgeon has used the tecnis lenses for many years and never experienced a reaction to the material.The surgeon verbalized that he did not think this issue was from the lens and felt it could be one of many other factors.It was mentioned that the surgeon uses a non-johnson & johnson brand of ophthalmic viscoelastic device (ovd) for all his surgeries.No further information available.The issue was reported with 4 patients.This report is for the patient four, first eye.Separate reports will be submitted for this patient's other eye and other three patients.

Manufacturer Narrative

Additional information/correction: additional information received from the doctor during follow-up indicated that "these cases are cases of endotheliitis with scientific scleritis and not endophthalmitis, presenting 2-3 weeks post-op uneventful cataract surgery.They do not fit in with the definition of tass (which occurs 1-2 days post cataract surgery) ".Based on the provided information, since ¿endophthalmitis¿ was inadvertently entered in section "b5" and "h6" of the initial mdr report which is incorrect; therefore, the information has been corrected in this supplemental mdr report.In review, it was also noted that the full name of the doctor was not correctly entered in the initial mdr report which is also being corrected in this supplemental mdr report.The following fields were updated accordingly: section e1: initial reporter name: (b)(6).Section h6: health effect - clinical code: 1932 - inflammation.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• 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: 13547004
• MDR Text Key: 289723320
• Report Number: 3012236936-2022-00423
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474619838
• UDI-Public: (01)05050474619838(17)240527
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P980040
• 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
• Report Date: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PCB00
• Device Catalogue Number: PCB000A165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2021
• 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
• Patient Outcome(s): Required Intervention