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

Model Number	DCB00
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a3a, a3b, a4, a5, a6: unknown/asked but unavailable (asku).Section d6a: if implanted, give date: not applicable, as lens was removed/replaced during the same procedure.Section d6b: if explanted, give date: not applicable, as lens was removed/replaced during the same procedure.Section e1: telephone number: (b)(6).Device evaluation: product evaluation was performed on a photograph the customer provided.The photo displays the suspect lens inside the patient's eye.The lens can be observed to be damaged at the edge.One lens haptic can be observed to be missing and detached from the lens.Due to no product received, no further evaluation could be performed and no further issues could be identified.The complaint issues "haptic detached" and "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.Therefore, there is no indication of a product deficiency or product malfunction.Based on the complaint investigation results, the product was released within specifications.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 this production order (po) was performed.The search of complaints revealed eight similar complaints for this production order number, however, the complaint issues reported are not related.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be confirmed.Attempts have been made to obtain missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a preloaded monofocal intraocular lens (iol) was inserted and a haptic was missing.The iol had to be removed.Another johnson & johnson lens (same model and diopter) was fully inserted as a replacement and removed during the same procedure, as the haptic was missing as well.It was also reported the lens was explanted during a secondary surgery.The patient status was unknown.It was unknown if an incision enlargement, sutures, or a vitrectomy were required.Through follow up, it was learned there was no secondary surgery on an another date performed.The lens implanted on the third try was another johnson & johnson lens (same model and diopter).There was no issues.It is unknown which serial number was the original lens or the replacement lens.No other information was provided.This report is for the intraocular lens model dcb00 serial number (sn) (b)(6).A separate report is being submitted to capture the dcb00 sn.(b)(6).
Additional Manufacturer Narrative
Additional information: it was confirmed through follow up that the lens with serial number (sn) (b)(6) was the first lens implanted.Sn (b)(6) was the replacement lens with missing haptic.No other information was provided.Device evaluation: a failure investigation (fi) was performed to further investigate the associated production order (po).Based on review, no conclusive cause can be determined as devices for the associated complaints have not been returned for evaluation.A non-conformance was opened to further investigate reported issue and corrective/preventive actions will be taken as appropriate in accordance with standard operating procedures.Based on the bounding review, no additional product orders were impacted.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: 20013688
• Report Number: 3012236936-2024-000224
• Device Sequence Number: 7123672
• Product Code: HQL
• UDI-Device Identifier: 05050474636057
• UDI-Public: (01)05050474636057(17)261104
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2024

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 Model Number: DCB00
• Device Catalogue Number: DCB0000185
• 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: 07/22/2024
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2023
• 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