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

Model Number ZA9003

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

Patient Problems Corneal Edema (1791); Inflammation (1932); Eye Pain (4467)

Event Date 01/11/2023

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2023, the patient underwent right eye cataract extraction during which an intraocular lens (iol) was implanted.Re-examination on surgery day showed visual acuity of 0.5 in the right eye, mild conjunctival congestion, mild corneal edema.On (b)(6) 2023, the patient complained of pain and discomfort.The visual acuity of the right eye was 0.3, conjunctival congestion, corneal edema, inflammatory exudation in the anterior chamber, large inflammatory exudation on the lens surface, and no significant abnormality in the fundus after mydriasis.Intraocular pressure was 9.0 mmhg.The following has been prescribed: prednisolone acetate eye drops 5 ml/vial 0.02 ml was applied to the right eye once a hour, levofloxacin eye drops 0.02 ml was applied to the right eye once a hour, tobramycin dexamethasone eye ointment was applied to the right eye once a night, atropine sulfate eye gel was applied to the right eye 3 times a day, sodium chloride injection 250 ml, dexamethasone sodium squamous solution injection 2 ml and ceftazidime for injection 3 g were intravenously infused once a day for treatment.No further information was provided.

Manufacturer Narrative

Weight and ethnicity: unknown/ not provided.Patient information cannot be provided due to personal data privacy legislation/policy.Explant date: explant date: not applicable, as lens remains implanted.Email address: unknown/not provided, as information was asked but not provided.Initial reporter telephone number: (b)(6).Device evaluated by mfr: the device is not returning for evaluation as 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.

• 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: 16464451
• MDR Text Key: 310491389
• Report Number: 3012236936-2023-00543
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474529175
• UDI-Public: (01)05050474529175(17)250707
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P990080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030280
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/07/2020
• 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 Age: 71 YR
• Patient Sex: Female