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

Model Number ZA9003

Device Problems Break (1069); Difficult to Insert (1316); Device Dislodged or Dislocated (2923)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/16/2023

Event Type  Injury  

Event Description

It was reported the johnson and johnson (jnj) intraocular lens (iol) would not fit in the sulcus correctly, the haptic kept sticking out.The doctor did not like the way it fit into the patient¿s right eye.On the same day but a separate procedure, the iol was explanted and another johnson & johnson lens (same model and 20.5 diopter) was implanted as a replacement.There were no debilitating symptoms resulting from this event.An unplanned vitrectomy was required.Reportedly, there was no capsule tear or sutures.Post operatively the patient was reported to be doing "great".No further information was provided.

Manufacturer Narrative

Section h6- health effect - impact code: 4625 used to capture the unplanned vitrectomy health effect ¿ clinical code: 4581 used to capture device decentered or dislocated or tilted subluxated or wrong position.Section h3-other (81): the device has not been returned for evaluation.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.Attempts have been made to obtain the missing information.However, to date, no response has been received.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: 17704292
• MDR Text Key: 322924427
• Report Number: 3012236936-2023-02131
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474529113
• UDI-Public: (01)05050474529113(17)270402
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/07/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/16/2023
• Initial Date FDA Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2022
• 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
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Race: White