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

Model Number	DXR00V
Medical Device Problem Codes	Break (1069); Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an intraocular lens (iol) did not deploy correctly, haptic was twisted.It was indicated that the was patient contact.No further information was provided.
Additional Manufacturer Narrative
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 were made to obtain the missing information; however, the information was not provided.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: in review, it was noticed that an incorrect establishment name (customer's establishment name) was inadvertently entered in the section "g1-2" of the intitial mdr report instead of manufacturer establishment name; therefore, the information has been corrected in this supplemental mdr report.Also, in review, since the device has been returned, an update of sections "d6a and d6b" were made in supplemental mdr report.The following fields were updated accordingly: section d6a: if implanted, give date: not applicable, there is no indication that the lens was implanted.Section d6b: if explanted, give date: not applicable, there is no indication that the lens was implanted.Hence, not explanted.Section g1-2: establishment name: johnson & johnson surgical vision, inc.Additional information: section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: mar 28, 2023.Section h3: device evaluated by manufacturer: yes.Device evaluation: the complaint lens was received stuck to the handpiece tray.The complaint handpiece was received as well.Visual inspection under magnification revealed no issues with the returned lens (including the haptics).No defects or assembly issues were observed with the handpiece before and after disassembling the handpiece for evaluation.Trace amounts of viscoelastic residue was observed in the handpiece cartridge which suggests an inadequate amount of ovd was used during loading and insertion which may lead to the reported complaint issues (however they were not confirmed during evaluation).Historical data analysis: a search of complaints related to this production order (po) was performed.The search revealed one additional complaint folder was received for this po for "stuck in cartridge" issue.Although, complaint issues reported are related, the issue could not be confirmed as related to manufacturing.Therefore, no escalations are required.Conclusion: based on the complaint investigation results, the product was released within specifications and a relationship between the device and the reported incident could not be determined.The complaint issue reported could not be confirmed and no product deficiency could be identified.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: 16612722
• Report Number: 3012236936-2023-00730
• Device Sequence Number: 17386459
• Product Code: POE
• UDI-Device Identifier: 05050474761742
• UDI-Public: (01)05050474761742(17)250421
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/21/2025
• Device Model Number: DXR00V
• Device Catalogue Number: DXR00VU175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2023
• Supplement Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 03/24/2023
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2022
• 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
• Patient Sex: Unknown