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

Model Number	DCB00
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: section d-6a date implanted: not applicable as the iol was not implanted.Section d-6b date explanted: not applicable as the iol was not implanted; therefore, not explanted.Section h-3 device evaluated by manufacturer: the complaint device was not returned for evaluation as it was discarded.Therefore, a failure analysis of the complaint device cannot be completed.A review of records including device history and complaint trending will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch report will be filed.Section h-6 health effect - impact code: 4624 - inferonasal iridotomy.Section h-6 health effect - impact code: 4625 - incision enlargement, sutures, vitrectomy.Section h-6 health effect - clinical code: 4581 - eye anatomy.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
Viscoelastic was injected into the capsular bag and the dcb00 model intraocular lens (iol) implant was injected.The iol was difficult to rotate into the capsular bag and vitreous was suspected.The iol was elevated out of the capsular bag and placed gently onto the iris.Superior subconjunctival lidocaine 2% without epinepherine was injected and a 23g trocar was placed in the superotemperal quadrant approximately 4 mm from the limbus.Anterior vitrectomy was performed.The anterior chamber was refilled with viscoelastic and the iol was trisected with intraocular scissors and removed.The incision was slightly enlarged and a 3 piece intraocular lens was placed into the ciliary sulcus and the optic captured.The temporal incision was closed with 10-0 nylon in a figure-of-eight configuration.The knot was cut, rotated, and buried.Anterior vitrectomy was performed within the anterior chamber to ensure no vitreous was present.An inferonasal iridotomy was created.All wounds were irrigated and 10-0 nylon was used to secure the superior and inferior paracentesis incisions.The knots were cut, rotated, and buried.The wounds were rechecked and found to be watertight.Miochol and moxifloxacin were injected into the anterior chamber.The trocar was removed and the sclerostomy was closed with a 8-0 vicryl suture in a figure of eight configuration.At the conclusion of surgery, the intraocular lens was well positioned in the patient¿s ocular sinister (left eye), all wounds were watertight, and the eye was left at a high physiologic pressure (low 20s by palpation).There was no product quality issue that contributed to the event; patient anatomy issue was confirmed.Patient prognosis post-procedure is unknown.The suspect iol is not available for return as it was discarded.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: 22688398
• Report Number: 3012236936-2025-000205
• Device Sequence Number: 6014299
• Product Code: HQL
• UDI-Device Identifier: 05050474636088
• UDI-Public: (01)05050474636088(17)280118
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 08/01/2025

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 Model Number: DCB00
• Device Catalogue Number: DCB0000200
• 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: 07/15/2025
• Initial Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2025
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 134 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White