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

Model Number ZCB00

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

Patient Problems Endophthalmitis (1835); Hypopyon (1913); Blurred Vision (2137); Loss of Vision (2139); Eye Pain (4467)

Event Date 07/28/2023

Event Type  Injury  

Manufacturer Narrative

Section a2, a4 and a5: unknown/ asked but not available.Section d6b: if explanted, give date: not applicable, as lens remains implanted.Section e1: reporter telephone number: (b)(6).Section h3: other 81: the device was not returned for evaluation as the lens remains implanted in the eye.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 had routine cataract surgery on (b)(6) 2023, phacoemulsification with intraocular lens (iol) implantation into the patient's operative eye.Post-operative visual acuity provided as 6/7.5 and on the subsequent two (2) visits readings were 6/6.On (b)(6) 2023 patient presented with painful eye and blurred vision.Account indicated that the patient had vision perception to light only and they had hypopyon.Aqueous and vitreous tap was done.Results were as follows: no gram stain, organisms identified, three (3) polymorph seen.After five (5) days, all four (4) culture plates had no growth.Patient had sterile endophthalmitis post-operatively.No further information was provided.

• 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: 17627483
• MDR Text Key: 322020091
• Report Number: 3012236936-2023-02173
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474531758
• UDI-Public: (01)05050474531758(17)260610
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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
• Report Date: 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/01/2023
• Initial Date FDA Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2022
• 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; Other