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 Code	Failure to Fold (1255)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	04/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the preloaded intraocular lens (iol) was removed from the right eye and replaced during the same procedure due to the lead haptic coming out and causing a tear in the capsule bag.The issue was observed after insertion.Another johnson and johnson iol was implanted as replacement (different model, zma00 (3-piece lens), different diopter, 19.0).There was no patient injury.A vitrectomy and sutures were required.No further information was required.
Additional Manufacturer Narrative
Section a4 and a5: unknown; requested but not provided.Section d6a: if implanted, give date: not applicable, as lens was removed/replaced during the same procedure.Section d6b: if explanted, give date: not applicable, as lens was removed/replaced during the same procedure.Section h3-other (81): 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, no additional information has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: additional information was received which reported that the lead haptic of the intraocular lens (iol) caught on the posterior capsule, causing it to tear.The iol was fully inserted and then removed and replaced with another device during the same procedure on (b)(6) 2023.On (b)(6) 2023, the patient had cornea edema and was referred to the retinal specialist.No medication was given to treat the edema.It is unknown if the corneal edema has resolved.The patient was supposed to return for follow-up on (b)(6) 2023, but the patient rescheduled appointment to (b)(6) 2023.No further information was provided.The following fields have been updated accordingly: section a5: ethnicity: hispanic/latino.Section a4: patient weight: 140 pounds.Correction: it was originally reported that section b3: date of event was apr 14, 2023, however, based on the additional information provided, the date of event was actually apr 13, 2023.The following field has been updated accordingly: section b3: date of event: apr 13, 2023.Please note that the information reported in sections d2 (common device name), h6 (health effect -clinical code and medical device problem code) and section g1 (manufacturer contact e-mail) is information that remains unchanged from the initial emdr report.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: 16857531
• Report Number: 3012236936-2023-01128
• Device Sequence Number: 15610122
• Product Code: POE
• UDI-Device Identifier: 05050474761797
• UDI-Public: (01)05050474761797(17)250725
• 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
• 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): 06/13/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/25/2025
• Device Model Number: DXR00V
• Device Catalogue Number: DXR00VU200
• 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: 04/14/2023
• Supplement Date Received by Manufacturer: 05/26/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 06/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2022
• 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 Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Hispanic