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

Model Number	DIB00
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A complaint was reported regarding the dib00 cartridge tip, which cracked during lens insertion.As the lens is advanced, the cartridge tends to crack near the tip, raising concerns about potential injury to patient.Despite the crack, the lens was successfully implanted without any adverse effects on the patient.It was indicated that the surgeon has experienced additional similar incidents.No further information was provided.Trough follow ups, the account mentioned that they use balanced salt solution (bss) at room temperature, which is introduced from the cartridge canopy.They do not open the lens until the end of phacoemulsification; at that point, they open the lens and prepare it for use.The dwell time is 3 to 4 minutes, and the surgical technician performs the initial advancement.The technician believes that the doctor applies a ¼ twist during the advancement process.It was confirmed that there have been no injuries in any of the cases, no interventions have been required, and the lenses have been successfully implanted and remain in place to date.Additionally, the patient's outcome have been good.No further information was provided.This emdr report pertains to the lens, model dib00, sn (b)(6).Separate reports will be submitted for the other incidents.
Additional Manufacturer Narrative
Section a2, a3a, a3b, a4, a5 and a6: unknown, information was requested but not available.Section d6b: if explanted, give date: not applicable as the device remains implanted section h3(no): the intraocular lens (iol) is not returning for evaluation as the lens remains implanted; 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.Attempts were made to obtain missing information; however, the account did not have the information.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: upon further review, it was noted that the code "4114" was inadvertently entered in the section "h6" of the initial mdr report instead of "4117"; therefore, the information has been corrected in this supplemental mdr report.The following field was updated accordingly: additional code added: section h6: type of investigation: 4117.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: a customer photo was provided and evaluated.The photo displays the suspect handpiece, and the plunger rod can be observed to be partially advanced.Due to the quality of the photo and no product received, no further evaluation could be performed.No issues were identified.The complaint issue "cartridge tip cracked/damaged" was not identified during photo evaluation.Conclusion: based on the investigation, no malfunction or product deficiency was identified.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: 21532105
• Report Number: 3012236936-2025-000064
• Device Sequence Number: 12546215
• Product Code: HQL
• UDI-Device Identifier: 05050474731844
• UDI-Public: (01)05050474731844(17)260417
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/16/2025

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 Expiration Date: 04/17/2026
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0240
• 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: 02/11/2025
• Supplement Date Received by Manufacturer: 03/12/2025; 03/16/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 03/16/2025; 03/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2023
• 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