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

Model Number	DFR00V
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the dfr00v intraocular lens (iol) was implanted in the patient's ocular sinister (left eye).There were patient complications and retinal surgery was performed.The iol remains implanted and is not available for return.No further information is available.
Additional Manufacturer Narrative
Date of event: unknown as information was not provided.Date explanted: not applicable, as the iol remains implanted.It was indicated that the iol is not being returned for evaluation as it remains implanted in the patient¿s os therefore, a visual analysis of the complaint device cannot be completed.A review of the device/lot history record and historical data analysis for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch report will be filed.(b)(4).Should additional information be received regarding this event the case will be reopened and processed accordingly.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information was received clarifying retinal surgery performed on (b)(6) 2022 was lens repositioning and the lens was not removed.Corrected data: based on updated information received 30-jun-2022 the following fields have been codes updated: section h-6: health effect - impact code: updated to 4625 - device repositioning.Previously reported code as 4625 - retinal surgery.Section h-6: health effect - clinical code: updated to 4581 - appropriate clinical signs, symptoms, conditions term/code not available (device decentered or dislocated).Previously reported code as 4580 - insufficient information (patient complications).Section h-6: medical device problem code: updated to 2923 - device dislodged or dislocated.Previously reported code as 2993 - adverse event without identified device or use problem.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.

• 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: 13808701
• Report Number: 3012236936-2022-00687
• Device Sequence Number: 11279972
• Product Code: HQL
• UDI-Device Identifier: 05050474750821
• UDI-Public: (01)05050474750821(17)240628
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 07/21/2022

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: 06/28/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU275
• 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: 03/02/2022
• Supplement Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 03/18/2022
• Supplement Report FDA Received Date: 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2021
• 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 Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian