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

Model Number	DCB00
Medical Device Problem Codes	Break (1069); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: patient weight: unknown as information was not provided.Date implanted: not applicable as the iol was not implanted.Date explanted: not applicable as the iol was not implanted.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported the intraocular lens (iol) haptic was stuck in the injector as the lens was being inserted into the patient's ocular sinister (left eye) and the haptic tore from the lens; there was patient contact with the product.The surgeon enlarged the wound, removed the lens and, sutures were placed.Through follow-up, additional information was received confirming no serious patient injury and no unplanned vitrectomy.The procedure was successfully completed using back-up lens with the same model and diopter size.No further information is available.
Additional Manufacturer Narrative
Corrected data: in review, it was noted that the product investigation was inadvertently not included in the initial emdr report; therefore, the product investigation information has been captured in this supplemental report.The following field was corrected accordingly: section h3: device evaluated by manufacturer: yes additional information: device evaluation: the product testing could not be performed as the product was not returned.The reported complaint cannot be confirmed.Manufacturing records review: the manufacturing process record was evaluated, and no discrepancies were found during the mrr (manufacturing record review) related to this complaint issue reported.The product was manufactured and released according to specifications.A search in complaint system revealed that no other complaints have been received for this production order number.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information was received, and the following fields were updated accordingly: section d-9: device available for evaluation: yes section d-9: date returned to manufacturer: 21-jun-2021 section h-3: device evaluated by manufacturer: yes device evaluation: the product returned consists in packaging components (folding carton, implant id, patient notification and labels) and a plastic container.Visual evaluation was performed, and the following were the findings: only the iol returned and it was inside a plastic container.The optic of the lens was cut and part of one (1) of the haptic is detached.Complaint issue reported was not verified.However, the condition in which the sample was returned is consistent with a product that was handled and prepared for a surgical process.Production deficiency can¿t be determined.Conclusion: as a result of the investigation, there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.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
• MDR Report Key: 11986270
• Report Number: 2648035-2021-07869
• Device Sequence Number: 14250608
• Product Code: HQL
• UDI-Device Identifier: 05050474636026
• UDI-Public: (01)05050474636026(17)231205
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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 faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/05/2023
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/11/2021
• Supplement Date Received by Manufacturer: 06/11/2021; 08/04/2021
• Initial Report FDA Received Date: 06/11/2021
• Supplement Report FDA Received Date: 06/11/2021; 08/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR