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

Model Number	DIB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section d6a: if implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Section d6b: if explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Section h3: other 81: the device was not returned for evaluation as the lens 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the patient underwent cataract surgery of the left eye.The surgery was uncomplicated and the cataract was successfully emulsified.Then implanted the tecnis simplicity eyhance preloaded intraocular lens (iol) following standard lens loading practices and no abnormalities were noted with the lens injector during the lens injection process.Upon implantation into the capsular bag, a lens defect was noted on the peripheral lens optic.The decision was made to explant the lens and exchange it with the backup same model and diopter iol, which was injected with no issues.The product was destroyed and discarded.Additional information received stated that there was an opacity noted in the peripheral lens optic that looked similar to a crack.Balanced salt solution (bss) from another manufacturer was used for cartridge lubrication at a room temperature.No additives used.Bss was introduced via a cannula into the hydration port to fill the cartridge completely.Just bss was used.It was in the dwell position for about 3 minutes.Surgical tech introduced bss into hydration port.Advanced plunger until it threads/clicks, then turned 1 times prior to handing off to surgeon.While advancing the lens, did small twists.Reportedly there was no use error, not that was made known.Surgeon has implanted multiple same lenses.There was no patient injury.Patient had good surgical outcome after intraocular lens exchange was performed.Incision enlargement was done to allow removal of bisected lens.No further information is available.

• Brand Name: TECNIS SIMPLICITY
• 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: 18240550
• Report Number: 3012236936-2023-03038
• Device Sequence Number: 3176505
• Product Code: HQL
• UDI-Device Identifier: 05050474731547
• UDI-Public: (01)05050474731547(17)250829
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/30/2023

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: 08/29/2025
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0095
• 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: 11/06/2023
• Initial Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2022
• 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
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White