MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS SIMPLICITY; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	DXR00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Flashers (1864)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a multifocal intraocular lens (iol) was explanted and replaced with a monofocal dcb00 lens due to patient complaining of starbursts.The surgery went well and no extension of the incision, no suture and no surgical complication reported.It was noted that the other eye still has the patients natural lens (no surgery).No further information was reported.
Additional Manufacturer Narrative
Unknown, information was requested but not provided.Section b3: date of event: unknown, not provided, but the best estimate date is between back in december and march 6, 2024.Section d4: catalog number: a complete catalog number is unknown, as the serial number was not provided.Section d4: serial number: unknown, information not provided.Section d4: expiration date: unknown, as the serial number was not provided.Section d4: udi number: unknown, as the serial number was not provided.Section d6a: if implanted, give date: unknown, not provided, but the best estimate date is back in december.Section h3-other (81): the device was not returned for evaluation and the serial number for this device is unknown/not provided; therefore, no further product investigation can be performed.Should any further relevant information become available a supplemental medwatch will be filed.Device manufacture date: unknown, as the serial number was not provided.Attempts have been made to obtain the missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.Complaint history review: a search of complaints related to this production order (po) was performed.The search revealed one additional complaint folder was received for this po.Although these complaint issues reported are related, the issue could not be confirmed as related to manufacturing.Therefore, no further actions are required.Conclusion: based on the investigation, no malfunction or product deficiency was identified.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.
Additional Manufacturer Narrative
Additional information: additional information provided indicated that the explanted lens was model dxr00v, 18.0 diopter, serial number (b)(6).It was noted that the lens was not saved.The following fields were updated accordingly: section d4: catalog number: dxr00vu180.Section d4: serial number: (b)(6).Section d4: expiration date: 07/01/2026.Section d4: udi number: (b)(4).Section d6a.If implanted, give date: (b)(6) 2023.Section h3 (no): 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.Section h4: device manufacture date: 07/01/2023.Corrected data: based on the new information received above, the information in the following fields were corrected/updated accordingly: section: d2: d2a.Common device name: extended depth of focus intraocular lens.Section: d2: d2b.Device product code: poe.Section d4: model number: dxr00v.Section h6: type of investigation: 4115 - device discarded.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SIMPLICITY
• 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: 19005307
• Report Number: 3012236936-2024-00992
• Device Sequence Number: 3944166
• Product Code: POE
• UDI-Device Identifier: 05050474761759
• UDI-Public: (01)05050474761759(17)260701
• 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: 2023
• Device Explanted Year: 2024
• 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,Followup
• Report Date (Section B): 06/28/2024
• 2 Devices were Involved in the Event: 1 2

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: 07/01/2026
• Device Model Number: DXR00V
• Device Catalogue Number: DXR00VU180
• 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: 03/06/2024
• Supplement Date Received by Manufacturer: 06/19/2024; 06/26/2024
• Initial Report FDA Received Date: 03/29/2024
• Supplement Report FDA Received Date: 06/20/2024; 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2023
• 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: 68 YR
• Patient Sex: Male