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

Model Number	DCB00
Medical Device Problem Codes	Inaccurate Delivery (2339); Difficult to Advance (2920); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: unknown, information not provided.If explanted, give date: unknown, information not provided.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) loaded incorrectly and would not insert completely, and kept popping out of the incision.Also, the lens would not advance appropriately into the patient's eye via the cartridge.The second lens used (same model and diopter) did advance appropriately.There was no incision enlargement, vitrectomy, or sutures required.There was no patient injury reported.Post-op patient was stable with no pain.No other information was provided.
Additional Manufacturer Narrative
Section d9.Device available for evaluation? yes returned to manufacturer on: 5/19/2021 section h3.Device evaluated by manufacturer? yes device evaluation: after the visual evaluation performed the following are the observations: lens was out of the device.The lens surface was covered with viscoelastic residues and the body lens is completely; no haptic detached was identified.No damage to the cartridge tip was observed, some residues of viscoelastic were present.The plunger and push rod were partially advanced position.The complaint issue was not verified.The condition in which the sample returned is consistent with a product that was handled and prepared for a surgical process.No product quality deficiency was identified.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
Device evaluation: the product was not returned.Therefore, the sample evaluation could not be performed, and the reported issue could not be verified.No product deficiency identified.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no additional complaints were received from this production order.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.

• 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: 11449814
• Report Number: 2648035-2021-07343
• Device Sequence Number: 3106113
• Product Code: HQL
• UDI-Device Identifier: 05050474635852
• UDI-Public: (01)05050474635852(17)231213
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/25/2021

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: 12/13/2023
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: 03/19/2021; 06/09/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 04/14/2021; 06/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL AND LOT# UNKNOWN; CARTRIDGE MODEL AND LOT# UNKNOWN