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

Model Number	PCB00
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: not applicable as the iol was not implanted.If explanted, give date: 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 during product handling and prior to insertion, the haptic detached from the pre-loaded intraocular lens (iol) and there was no patient contact.Outcome does not significantly interfere with activities of daily life.Through follow up, additional information was received confirming the same procedure was completed successfully using back-up lens with the same model and diopter size.No further information is available.
Additional Manufacturer Narrative
Additional information: device evaluation: product testing could not be performed because the product was not returned.A product quality deficiency could not be confirmed.The reported issue was not verified.Manufacturing records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification.Historical data analysis: a search revealed that no other complaints for this production order number have been received.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.
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: returned to manufacturer: yes.Section d-9: date returned to manufacturer: 10-apr-2021 section h-3: device evaluated by manufacturer: yes device evaluation: the sample was received in the original box.The plunger was not advanced.All the components were correctly engaged to the device.No assembly error and/or defect related to manufacturing process were observed.Traces of lubricating material residues was observed in the device indicating that the product was handled and prepared for surgical process.The lens was stuck at the cartridge tube and the haptic appears to be detached.Device was opened to verify the reported condition.The reported issue was verified; however, due to the condition of the sample returned it is not possible to determine it is related to handling of the product or to the manufacturing process.Based on the analysis product quality deficiency could not 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 IOL
• 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: 11408446
• Report Number: 2648035-2021-07264
• Device Sequence Number: 3631185
• Product Code: HQL
• UDI-Device Identifier: 05050474558243
• UDI-Public: (01)05050474558243(17)221029
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/28/2021

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: 10/29/2022
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 03/04/2021; 04/21/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 03/31/2021; 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1