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

Model Number DIB00

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

Patient Problems Corneal Edema (1791); Inflammation (1932); Intraocular Pressure Increased (1937); Blurred Vision (2137); Eye Pain (4467); Toxic Anterior Segment Syndrome (TASS) (4469)

Event Date 06/08/2021

Event Type  Injury  

Manufacturer Narrative

Ethnicity: unknown/ not provided.Explant date: if explanted, give date: not applicable, as lens remains implanted, not explanted.The device is not returning for evaluation as lens remains implanted; therefore, a failure analysis of the complaint device cannot be completed.A review of the device/lot history record and complaint trending 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 there were 6 cases of toxic anterior segment syndrome (tass).It was learned that for this event, the visual symptoms are not debilitating.The patient presented with history of significant pain, blurred vision since the evening of surgery, diffuse corneal edema, elevated intraocular pressure (iop) to 60 mmhg, mild anterior segment inflammation, originally thought edema secondary to elevated iop but with lowering of iop, limbal to limbal edema persisted and then considered to be tass treatment provided was intensive topical steroids and iop meds.The following meds were also given but was noted as the doctor's standard care, prolensa everyday, inveltys 2x/day, moxifloxacin 2x/day, lumigan , combigan 2x/day, simbrinza 2x/day, diamox 500 mg tablets.It was stated that current patient status is the iop normal, corneal edema resolved, pupil remains enlarged possibly related to elevated iop with iris ischemia and or secondary to possible tass, best corrected visual acuity (bcva) 20/30.Intraocular lens (iol) remains implanted.No additional medical or surgical intervention required.The other products are not being returned for evaluation.Additional information received noted that the customer investigated the cases.However, root cause for the tass has not been determined.No other information was provided.This report is 6 of 6 cases for tass capturing the event for the intraocular lens (iol).Separate reports are being submitted for each of the other products involved.

• 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 ; road 402 north, anasco ind. pk; anasco, PR 00610 ; 7142478552
• MDR Report Key: 12204886
• MDR Text Key: 262726763
• Report Number: 2648035-2021-08178
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474731783
• UDI-Public: (01)05050474731783(17)240426
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/26/2024
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2021
• 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
• Patient Weight: 82