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

Model Number	DFR00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Discomfort (2330)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an intraocular lens (iol) was explanted from the patient's right eye due to the patient could not tolerate the lens.The patient could not adapt to it despite giving her nearly 3 months.No other information was provided.Patient had bilateral lens implants.This report captures the lens implanted in patients right eye.A separate report will be filed for the left eye.It was reported that an intraocular lens (iol) was explanted from the patient's left eye as the patient could not tolerate the lens.The iol exchange proceeded uneventfully and the new johnson & johnson dib00 lens was put in the bag.No other information was provided.Patient had bilateral lens implants.This report captures the lens implanted in patients left eye.A separate report will be filed for the right eye.
Additional Manufacturer Narrative
Date of event: the exact date is unknown, the best estimate is prior to (b)(6) 2022.If explanted; give date: the exact date of explant is unknown, the best estimate is 6 weeks earlier than (b)(6) 2022.The device was not 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 missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
In reviewing the initial mdr, it was noticed that the patients eye was addressed inappropriately in b5 as the right eye.The correct eye was the left eye.Therefore, it is captured in this supplemental report.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: 14627660
• Report Number: 3012236936-2022-01500
• Device Sequence Number: 5077311
• Product Code: HQL
• UDI-Device Identifier: 05050474750715
• UDI-Public: (01)05050474750715(17)240923
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2022

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 Expiration Date: 09/23/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU220
• 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: 05/12/2022
• Supplement Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 11/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2021
• 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 Age: 76 YR
• Patient Sex: Female