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

Model Number	DCB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a preloaded monofocal intraocular lens (iol) touched the eye when the surgeon noticed that a chunk of the lens was missing, so the surgeon took the lens out and replaced it with the back up iol.Through follow up, it was confirmed that the iol was cut out and replaced and that there was no patient injury during the surgery.No further information was provided.
Additional Manufacturer Narrative
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 e1: telephone number: (b)(6).Section h3: 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.An attempt has been made to obtain missing information.However, the account did not provide the information.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: upon further review, it was noticed that the following information was inadvertently not included; therefore, it is captured in this supplemental report: device evaluation: the device was not returned at the manufacturing site; therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.A search of complaints related to this production order (po) was performed.The search of complaints revealed two other complaints were received under this production order and the complaint issues were not related.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be confirmed.The following sections have been updated accordingly: section h6: type of investigation: 4109- historical data analysis, 3331 - analysis of production records.Section h6: investigation findings: 213 - no device problem found.Section h6: investigation conclusions: 67 - no problem detected all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional info: section d9: device available for evaluation? yes section d9: returned to manufacturer on: 4/8/2025.Section h3: device evaluated by manufacturer¿ yes device evaluation: the complaint handpiece was received inside a biohazard bag along with the lens wrapped in gauze.Visual inspection under magnification revealed the complaint handpiece was received with the plunger rod fully advanced.Viscoelastic residue was observed to be evenly distributed throughout the cartridge.Stress marks were observed on the cartridge tip but were in specification for a used device.No cartridge tip or cartridge issues were observed.The lens module was inspected revealing no issues or viscoelastic residue.Device assembly was inspected revealing no issues.Plunger rod advancement was inspected revealing no issues; the plunger rod was observed to be bent.The lens was inspected revealing it was received cut in half and coated in viscoelastic residue.The lens halves were cleaned revealing one lens half was scratched with the haptic damaged; the other lens half had damage near and at the edge of the lens.The complaint issue "lens damaged" was identified during product evaluation.However, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.The other observed issues during the product evaluation could not be confirmed to be related to the manufacturing or design process.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be confirmed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• 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: 21767749
• Report Number: 3012236936-2025-000090
• Device Sequence Number: 15569166
• Product Code: HQL
• UDI-Device Identifier: 05050474636071
• UDI-Public: (01)05050474636071(17)271018
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/09/2025

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 Model Number: DCB00
• Device Catalogue Number: DCB0000195
• 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: 03/10/2025
• Supplement Date Received by Manufacturer: 04/03/2025; 05/16/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 04/04/2025; 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2024
• 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: Male