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

Model Number	ZA9003
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intraocular Pressure Increased (1937)
Date of Event	01/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the za9003 intraocular lens (iol) was fully inserted into the patient's ocular dexter (right eye).The iol was removed due to an increase in aqueous pressure and pushed forward and did not allow for original lens to be placed in the correct position in the bag.Since lens was not in a good position it needed to be removed and was replaced with a sulcus lens, diopter size unknown.Iol is not available for return as it was discarded.Patient outcome post-procedure was reported as recovered.No further information is available.
Additional Manufacturer Narrative
Patient weight and ethnicity and race: unknown/asked information unavailable.Date implanted: not applicable, as the iol was removed and replaced during the same procedure.Date explanted: not applicable, as the iol was removed and replaced during the same procedure.The device was not returned 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.Health effect - impact code: 4631 iol removal and replacement attempts were made to contact the customer account requesting additional information regarding complaint 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
• Common Device Name: 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: 16561041
• Report Number: 3012236936-2023-00677
• Device Sequence Number: 5691392
• Product Code: HQL
• UDI-Device Identifier: 05050474528963
• UDI-Public: (01)05050474528963(17)270828
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/16/2023

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
• Operator of Device: Health Professional
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 03/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male