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

Model Number	DCB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: section d-6a date implanted: not applicable as the iol was removed and replaced during the same procedure.Section d-6b date explanted: not applicable as the iol was removed and replaced during the same procedure, therefore not explanted.Section h3-81: 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, 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 report will be filed.An attempt was made to contact the customer account requesting additional information regarding complaint 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 upon insertion the dcb00 model intraocular lens (iol) was damaged by the loader/plunger.The iol was removed from the patient and the back-up iol was inserted into the patient¿s ocular sinister (left eye).There was no medical and/or surgical intervention.Patient status post-operatively was reported as no complications.Balanced salt solution (bss) was used at room temperature.After inserter preparation there were no surgery delays before an attempt was made to advance the iol.No further information is available.
Additional Manufacturer Narrative
Additional information: through follow-up, additional information was received confirming the suspect iol was fully implanted.The same procedure was completed successfully using back-up dcb00 17.5 diopter iol.Patient weight, ethnicity, and race information was also provided.No further information is available.The following patient information sections have been updated accordingly: section a-4 weight: 185lbs.Section a-5 ethnicity: not hispanic/latino.Section a-5 race: white/caucasian.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d-9: device available for evaluation: yes.Section d-9: device date returned to manufacturer: 26-jan-2024.Section h-3: device evaluated by manufacturer: yes.Device evaluation: a customer provided photograph was received.The complaint simplicity was received inside a plastic bag however no lens was received.The customer provided photograph was evaluated.Displayed was an implanted lens with two marks on the optic body of the lens.No further evaluation can be performed from a photographic assessment.Complaint issue of dc-lens damaged was identified during product 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 simplicity was visually inspected under magnification no issues with the cartridge, plunger rod, or handpiece were observed that could cause or contribute to the complaint issue was observed.No suspect lens was received for evaluation.Conclusion: based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction 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: 18509181
• Report Number: 3012236936-2024-00104
• Device Sequence Number: 8125241
• Product Code: HQL
• UDI-Device Identifier: 05050474636033
• UDI-Public: (01)05050474636033(17)250525
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/11/2024

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: 05/25/2025
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000175
• 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: 12/19/2023
• Supplement Date Received by Manufacturer: 01/15/2024; 03/08/2024
• Initial Report FDA Received Date: 01/12/2024
• Supplement Report FDA Received Date: 01/16/2024; 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2022
• 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: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White