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

Model Number	DCB00
Medical Device Problem Codes	Break (1069); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section d6b: if explanted, give date: not applicable, remains implanted in the eye.Section e1: initial reporter: telephone number: (b)(6).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.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the surgeon encountered difficulty with the preloaded monofocal intraocular lens feeling stuck during the final turns of the lens cartridge.Upon releasing and opening the lens inside the patient's eye, damage to the lens was observed.The surgeon opted to leave the damaged lens in place temporarily, noting that the patient might not exhibit symptoms related to the damage.Additionally, the surgeon remarked that the issue of the model dcb00 lens getting stuck has become a recurrent problem.No other information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation; however, a (photo or video) was received.Additional information: device evaluation: customer provided photos were evaluated by a post market safety surveillance officer.The photos showed a pseudophakic eye implanted with an intraocular lens claimed to be a tecnis monofocal iol preloaded in the simplicity delivery system (model dcb00).A triangular shaped mark can be observed located in the lens mid periphery at 11:00 ¿ 11:30 (in relation with the picture orientation).The actual root cause and definitive clinical impact of the observed marks cannot be determined from a picture assessment; however, due to its location, it might not represent risk of clinical impact in the event a lens remains implanted.The complaint issue lens damaged was identified during photo 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 complaint issue difficult to use was not identified during photo evaluation.Conclusion: based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction could be identified.Additional information received which reported that the lens damage was at the optic off-center.There were no reports of visual issues or user error, and it was reported that there was no noticeable impact on the patient during the final follow-up.No additional information was provided.Section b5: it was reported that the surgeon encountered difficulty with the preloaded monofocal intraocular lens, which felt stuck during the final turns of the lens cartridge.Upon releasing and opening the lens inside the patient's eye, damage to the lens was observed.The surgeon decided to leave the damaged lens in place temporarily, noting that the patient might not exhibit symptoms related to the damage.The surgeon also mentioned that the issue of the dcb00 lens getting stuck had become a recurrent problem.Upon follow-up, it was revealed that the lens damage was at the optic off-center.There were no reports of visual issues or user error, and it was reported that there was no noticeable impact on the patient during the final follow-up.No additional information was provided.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: 22215560
• Report Number: 3012236936-2025-000166
• Device Sequence Number: 20898576
• Product Code: HQL
• UDI-Device Identifier: 05050474636095
• UDI-Public: (01)05050474636095(17)270508
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2025

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: DCB0000205
• 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: 05/19/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2024
• 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: Unknown