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	03/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Weight/ethnicity: information unknown/not provided.If implanted; give date: n/a (not applicable).The intraocular lens was inserted and removed during the same procedure.If explanted; give date: n/a (not applicable).The intraocular lens was inserted and removed during the same procedure.Device evaluation: the device was not returned at the manufacturing site; therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that no similar complaint for this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be confirmed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) was fully inserted in the left eye and removed during the same procedure as the trailing haptic was missing/detached.No further information is available.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation? yes section d9: returned to manufacturer on: 5/24/2021 section h3: device evaluated by manufacturer¿ yes device evaluation: the returned sample was received consisting in packaging components (folding carton, implant card & labels) and preloaded system pcb00 device.Visual evaluation was performed.Lens was stuck in cartridge.Pcb00 returned disarmed.The device was observed bent.Preloaded device was in advance position.No damage to the cartridge or cartridge tip was found.It was too hard to remove the lens from the cartridge to address the condition reported.Complaint issue reported ¿haptic detached¿ was not verified.However, the condition in which the sample returned is consistent with a product that was handled and prepared for a surgical process.Production deficiency can not be determined.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be confirmed.Corrected data: in the initial mdr, section h6 conclusion code was inadvertently not populated with code 67.The following section has been updated accordingly: section h6: investigation conclusions: 67- no problem detected.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: 11758495
• Report Number: 2648035-2021-07729
• Device Sequence Number: 3192537
• Product Code: HQL
• UDI-Device Identifier: 05050474558069
• UDI-Public: (01)05050474558069(17)210815
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Report Date (Section B): 09/16/2021

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: 08/15/2021
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/05/2021
• Supplement Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR