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

Model Number	DCB00
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Material Opacification (1426)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a5: ethnicity: unknown/not provided.Section d6a: if implanted, give date: not applicable, as lens was inserted and then removed in the same procedure.Section d6b: if explanted, give date: not applicable, as lens was inserted and then removed in the same procedure.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.
Event or Problem Description
It was reported that during the unfolding process of a single-piece preloaded monofocal intraocular lens (iol), a central inclusion defect that resembled a bubble was observed.The doctor used micro scissors and forceps to cut and remove the lens in pieces.Subsequently, a replacement iol was implanted without complications.The lens loader preparation and insertion process went smoothly and without issues.The tech and the doctor stated that the issues that occurred were not caused by an error during prepping, loading, or insertion.There was patient contact.Additional information was received and stated that the iol was fully implanted in the patient's left eye when the malfunction was observed.The replacement was a non-johnson and johnson iol.There were no reported patient injuries.No unplanned surgical interventions such as, incision enlargement, sutures, or vitrectomy.No medication prescribed that was outside of the standard of care.The patient outcome is good.No further information was provided.
Additional Manufacturer Narrative
Corrected data: in reviewing the initial mdr 3012236936-2026-0000275, it was noticed that the "type of investigation" codes 4109 (historical data analysis) and 3331 (analysis of production records) along with the narrative to support the "type of investigation" codes was inadvertently not included; therefore, it is captured in this supplemental report: manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search of complaints related to this production order (po) was performed.The search revealed that no similar complaints for this po number have been received.The following fields have been updated accordingly: section h6: type of investigation: code 4109 (historical data analysis) and code 3331 (analysis of production records) all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
The product was received for evaluation.Device evaluation: visual inspection revealed that the handpiece was received with the plunger rod fully advanced.Viscoelastic residue was observed throughout the cartridge; stress marks were observed on the cartridge tip.The cartridge tip and cartridge was damaged.No issues were identified with the lens module, device assembly, and plunger rod advancement.The plunger rod tip was slightly bent.The lens was received cut in half and coated in viscoelastic residue; one lens half had a detached haptic.The lens halves were cleaned revealing that the lens was damaged and scratched; no bubble was observed.The complaint issue "inclusions" was not identified during product evaluation.The observed "lens damaged" is similar to the reported complaint issue.However, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process conclusion: based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction could be identified.The following fields were updated accordingly: section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: jan 26, 2026.Section h3: device evaluated by manufacturer: yes.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: 24225075
• Report Number: 3012236936-2026-000027
• Device Sequence Number: 12860126
• Product Code: HQL
• UDI-Device Identifier: 05050474636071
• UDI-Public: (01)05050474636071(17)281023
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Followup
• Report Date (Section B): 04/09/2026

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
• 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: 01/06/2026
• Supplement Date Received by Manufacturer: 02/10/2026; 03/20/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 03/06/2026; 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2025
• 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
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 74 KG
• Patient Race: White