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

Model Number	DCB00
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when lens was inserted into the patient's eye, the haptics stuck to the intraocular lens (iol) optic and would not unfold.Duovisc viscoelastic was used.The surgeon tried to release haptics with bss and provisc and manipulated with drysdale.The haptics eventually unfolded.Surgery was delayed for 5 minutes.There was no interventions performed.No further information was provided.
Additional Manufacturer Narrative
Section a2,a3, a4 and a5: unknown/not provided.Section d6b: if explanted, give date: not applicable, as lens was remained implanted.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 and complaint trending 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.
Additional Manufacturer Narrative
The product was returned to the manufacturing site for evaluation.Additional information: section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: september 3, 2025.Section h3: evaluated by manufacturer: yes.Device evaluation: the original folding carton and patient stickers were received.No lens or handpiece was received for evaluation.Product evaluation was not performed because the suspect product has not been received.If product is received after initial closure, the product investigation and complaint file may be re-opened to complete the return investigation.The complaint issue reported could not be confirmed.Based on the complaint investigation results, the product was released within specifications.The complaint issue reported could not be confirmed and no product deficiency or product malfunction could be identified.No nonconformity report, documentation or labeling changes, and escalations are required.Johnson & johnson surgical vision will continue to monitor these types of complaints.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: 22867973
• Report Number: 3012236936-2025-000214
• Device Sequence Number: 15767494
• Product Code: HQL
• UDI-Device Identifier: 05050474636125
• UDI-Public: (01)05050474636125(17)271118
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2025

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: DCB0000220
• 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: 07/28/2025
• Supplement Date Received by Manufacturer: 09/12/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2024
• 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 Age: 81 YR
• Patient Sex: Male