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

Model Number	DIB00
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: not applicable, the lens was not implanted.If explanted, give date: not applicable, the lens was not implanted, therefore it was not explanted.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a dib00 model intraocular lens(iol) had bad haptic and would not advance.The lens did not touch/contact the patient's eye.There was no patient injury.No medical/ surgical intervention was required.Additional details received confirms that haptic was damaged and the lens did not advance from staging phase.Procedure was completed successfully using backup lens of same model and diopter.No further information available.
Additional Manufacturer Narrative
Section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: 8/27/2021.Section h3: device evaluated by manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection revealed that the complaint lens was returned stuck at the cartridge tip and that the cartridge tip had cracked.There was no assembly issue identified with the handpiece, the device plunger was in an advanced position.Trace amount of viscoelastic residues were observed inside the cartridge tip and on the lens.The cartridge tip was cracked and lens damage was observed which can be attributed to an inadequate amount of ovd in the cartridge during deployment (viscoelastic residue is only observed in and near the cartridge tip).The lens was removed from the cartridge tip and lens damage and detached haptics (similar to dc-haptic damaged but cannot confirm the complaint issue due to definitions provided by amo-04-d024) were observed which can be attributed to handling of the lens during deployment and also removal of the damaged lens from the cartridge tip.Dc-device advancement issues cannot be confirmed because the viscoelastic residue in the cartridge suggests an inadequate amount of ovd was used during deployment.The complaint issue could not be confirmed and no product deficiency could be identified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.The search revealed no additional complaints from this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.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: 12340723
• Report Number: 2648035-2021-08316
• Device Sequence Number: 4536334
• Product Code: HQL
• UDI-Device Identifier: 05050474731653
• UDI-Public: (01)05050474731653(17)240507
• 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): 10/07/2021

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: 05/07/2024
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/20/2021
• Supplement Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 08/19/2021
• Supplement Report FDA Received Date: 10/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR