MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS SIMPLCTY TECNIS SYMF ERV OB; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	DXR00VU220
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	02/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the intraocular lens (iol) was explanted from the left eye due to the patient being unhappy with near vision with the implanted lens and requesting the surgeon to give the patient better near vision "10 pt".The issue was first observed during a post-operative examination.Daily activities were not significantly affected.Symptoms persisted for 2.5 months and there was a 2.5 month delay in procedure.A non-johnson and johnson iol was implanted as replacement for goal (+24.0d).No incision enlargement, vitrectomy, or suture was required.No medication was prescribed outside the standard of care.Directions for use were followed.Pre-operative best corrected visual acuity (bscva) was 20/20 and post-operative bscva was 20/20.No patient injury was indicated.No further information was provided.
Additional Manufacturer Narrative
Device evaluation: the device was not returned at the manufacturing site; therefore, product testing could not be performed, and the customer¿s reported complaint could not be verified.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search of complaints related to this production order (po) was performed.The search revealed that no similar complaints for this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be confirmed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
The product was received for evaluation.Additional information: section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: jun 7, 2023.Section h3: evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed that the complaint lens was received coated in viscoelastic residue.The lens was cleaned and, no issues that could cause or contribute to or cause the complaint issue could be identified.The complaint issues could not be confirmed to be related to the manufacturing or design process.Conclusion: as per complaint investigation results, the product was released within specifications.Therefore, there is no indication of a product deficiency or product malfunction.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SIMPLCTY TECNIS SYMF ERV OB
• Common Device Name: EXTENDED DEPTH OF FOCUS 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: 16935851
• Report Number: 3012236936-2023-01234
• Device Sequence Number: 5822840
• Product Code: POE
• UDI-Device Identifier: 05050474761834
• UDI-Public: (01)05050474761834(17)250729
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2023

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 Expiration Date: 07/29/2025
• Device Model Number: DXR00VU220
• Device Catalogue Number: DXR00VU220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/19/2023
• Supplement Date Received by Manufacturer: 06/26/2023
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2022
• 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 Age: 56 YR
• Patient Sex: Female
• Patient Weight: 53 KG
• Patient Ethnicity: Hispanic
• Patient Race: White