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

Model Number	DCB00
Medical Device Problem Codes	Use of Device Problem (1670); Mechanical Jam (2983)
Health Effect - Clinical Codes	Eye Injury (1845); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a3b, a4, a5 and a6: unknown, information not provided.Section d6a: if implanted, give date: not applicable, as there is no indication that the lens was implanted.Section d6b: if explanted, give date: not applicable, as there is no indication that the lens was implanted.Section e1: initial reporter: email address: unknown, information not provided.Section e1: initial reporter: 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 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 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 had a three-year decline in vision in both eyes and aggravated vision for one year.He underwent phacoemulsification and intraocular lens implantation for the left eye and during implantation of the intraocular lens, it was found that the intraocular lens was stuck in the injector and could not be pushed out.The intraocular lens was damaged and could not be implanted.The operation was stopped.The intraocular lens was then reimplanted where the patient had to undergo a second operation and multiple anesthesia, which caused secondary damage and increased the patient's hospitalization time.There was no other delay in treatment or other interventions performed.No further information was provided.
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: august 26, 2025.Section h3: evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification was performed on the cartridge was damaged and the cartridge tip was cracked and damaged.The plunger rod was also observed to be damaged.Ovd was observed inside the cartridge.The lens module was opened and inspected and ovd was observed inside.The handpiece was inspected, and no issues were identified.The lens was inspected and was observed to be coasted in viscoelastic residue.The lens was cleaned and inspected and was observed to be damaged with a detached haptic.No further evaluation was performed.The complaint issue "stuck in cartridge" was not identified during product evaluation.However, the complaint issue "use error" was confirmed as it was stated the lens "was reimplanted".Based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.Hra (health risk assessment) and human risk factor documents were reviewed for the complaint issue reported.The results of this hra and human risk factors review do not confirm that the above situations occurred during manufacturing, and are only provided for informational purposes; therefore, no further escalations are required.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: 22193945
• Report Number: 3012236936-2025-000156
• Device Sequence Number: 13058667
• Product Code: HQL
• UDI-Device Identifier: 05050474636095
• UDI-Public: (01)05050474636095(17)280108
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2025

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: DCB0000205
• 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: 05/19/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2025
• 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: 70 YR
• Patient Sex: Female