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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Weight and ethnicity: unknown, not provided.Date of event is unknown.The best estimate time would be (b)(6) 2021.If implanted; give date: n/a (not applicable).Lens was removed/replaced during the same procedure.If explanted; give date: n/a (not applicable).Lens was removed/replaced during the same procedure.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a tecnis simplcty preloaded intraocular lens (iol) was damaged as implanted in the patient's eye.The lens was removed and replaced with a back up lens during the initial procedure.Reportedly, the patient is doing fine post-surgery.No further information provided.
Additional Manufacturer Narrative
Section d9: device available for evaluation? yes.Returned to manufacturer on: 6/18/2021.Section h3: device evaluated by manufacturer? yes.Device evaluation: complaint product was received.It was returned, in its original packaging.Also, patient identification card, patient notification card and labels were received.Upon evaluation of the sample received, the plunger was in advanced position, and the pushrod looks centered.All the components were correctly assembled, and no defect related to manufacturing process was identified.Traces of lubricating material were observed, in the cartridge.The lens got stuck in the cartridge tip with the leading haptic not folded.A bump can be observed, at the cartridge tube.As the lens is to hard inside the device, it is not possible to remove it.Therefore, the reported lens damaged could not be verified.Based in the analysis product, quality deficiency could not 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: 11766692
• Report Number: 2648035-2021-07728
• Device Sequence Number: 17301948
• Product Code: HQL
• UDI-Device Identifier: 05050474636231
• UDI-Public: (01)05050474636231(17)231205
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Date (Section B): 07/23/2021

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: 12/05/2023
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/05/2021
• Supplement Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 05/03/2021
• Supplement Report FDA Received Date: 07/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR