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

Model Number ZCU150

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

Patient Problems Corneal Edema (1791); Eye Injury (1845)

Event Date 08/23/2022

Event Type  Injury  

Manufacturer Narrative

If explanted, give date: not applicable, as the lens remains implanted.The device was not returned 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.

Event Description

It was reported that after the intraocular lens (iol) was implanted, the patient was doing well, but experiencing some mild to moderate corneal edema at the wound.The patient's uncorrected vision is 20/40 post operative day 2.Through follow-up it was learned that the cornea edema was first noted on the first post-operative day, (b)(6) 2022.The surgeon added prednisolone acetate 1% qid, tapering by one drop each week to the pred/moxi/brom used that was used (with the same instructions) in order to speed the resolution of corneal edema.The patient is finished with those drops now.The patient no longer has corneal edema but still has trace descemet's folds at the wound.The patient's best corrected vision is 20/25 with -0.25 +0.50 x 90.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: 15601892
• MDR Text Key: 301729083
• Report Number: 3012236936-2022-02589
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474657809
• UDI-Public: (01)05050474657809(17)261114
• 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: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ZCU150
• Device Catalogue Number: ZCU150U205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2021
• 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 Age: 65 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White