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

Model Number	DCB00
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the preloaded intraocular lens(iol) was fully inserted into the patient left eye.But the lens was not implanted into the eye correctly.So the doctor removed the lens and used the back up lens to complete the procedure.Sutures were needed, and there was a delay in the procedure.From additional information it was it was learnt that the lens did not implant correctly.It was not sure if there was product quality issue.No other information is available.
Additional Manufacturer Narrative
Section a3b, a4 and a5: unknown/ asked but not available.Section b3: date of event: unknown, not provided, section d6a: if implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Section d6b: if explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Section e1: surgeon's email address: unknown/ asked but not available.Section h3: other 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 will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: 9/11/2024.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection of the complaint device reveal the plunger rod was partially advanced.The lens was stuck in the cartridge tip and the cartridge tip was slightly bent.The lead haptic was unfolded however once the lens is partially delivered the leading haptic begins unfolding therefore the haptic is within specification.The lens module was inspected and presented with no damage or viscoelastic residue.The device assembly was inspected and presented with no issues.The plunger rod advancement was inspected and resistance was felt.The lens was attempted to be removed from the cartridge tip without success; no further evaluation can be performed.Based on further review, it was determined that there could have been product malfunction due to the resistance from the handpiece that could contribute to the reported complaint issue.A non-conformance has been opened to further investigate this issue and appropriate corrective and preventive actions will be taken in accordance with our standard operating procedures.Based on the bounding review, there are six (6) production orders associated with the noted resistance in this complaint.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.A search of complaints related to the associated production order (po) was performed.The search of complaints revealed that no similar complaint for the relevant production order.Conclusion: although a definitive root cause has not been confirmed at this time, johnson & johnson surgical vision, inc.Will continue to monitor these types of events.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: 20302870
• Report Number: 3012236936-2024-000251
• Device Sequence Number: 7745025
• Product Code: HQL
• UDI-Device Identifier: 05050474636255
• UDI-Public: (01)05050474636255(17)260921
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2024

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: 09/21/2026
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2024
• 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: 08/29/2024
• Supplement Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female