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

Model Number	DCB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol), model dcb00, was removed and replaced in the same procedure due to a lens issue.Account indicated that the lens was partially inserted in the patient's right eye when doctor noticed lens was faulty and retracted it back into the cartridge.The procedure was completed using another johnson and johnson iol of the same model and diopter.No further information is available.
Additional Manufacturer Narrative
Section d9.Device available for evaluation? yes date returned to manufacturer: september 1, 2021 section h3.Device evaluated by manufacturer? yes device evaluation: visual inspection revealed that the device returned with the lens stuck at the cartridge tip.Part of the lens is observed damaged out of the cartridge tip.There was no assembly issue identified neither cartridge damaged, the device plunger was in advance position.Traces of viscoelastic residues were observed inside the cartridge.The reported issue was verified; however, due to the condition in which the sample returned it is not possible to determine the condition observed is related to handling or to the manufacturing process.Based on the sample evaluation and the handling process observed with the device, no product deficiency could be determined.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: 12321496
• Report Number: 2648035-2021-08312
• Device Sequence Number: 2825913
• Product Code: HQL
• UDI-Device Identifier: 05050474636019
• UDI-Public: (01)05050474636019(17)230313
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 10/26/2021

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: 03/13/2023
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 10/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR