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

Model Number ZA9003

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Blurred Vision (2137); Zonular Dehiscence (2698); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/06/2022

Event Type  Injury  

Event Description

It was reported that after the full insertion of an intraocular lens (iol) into a patient¿s left eye, the lens sunk due to loose zonules.The patient experienced blurry vision.The lens was removed and replaced in a separate procedure and a non-johnson and johnson lens of +18.5 diopter was used as the replacement.No other interventions were mentioned.The patient has recovered.The device will not be returned as it was discarded at the site.No further information was provided.

Manufacturer Narrative

Unknown, information was requested but not provided.Phone number: (b)(6).The intraocular lens (iol) is not returning for evaluation as it was discarded; 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.(b)(4) this code was used for device decentered or dislocated or tilted subluxated or wrong position.An attempt was made to obtain missing information; however, the information was not provided.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: 15332584
• MDR Text Key: 299039628
• Report Number: 3012236936-2022-02308
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474529045
• UDI-Public: (01)05050474529045(17)240520
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2019
• 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
• Treatment: EMERALDC30 CARTRIDGE, LOT CJ25821
• Patient Outcome(s): Required Intervention
• Patient Sex: Male