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

Model Number	DCB00
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information cannot be provided due to personal data privacy legislation/policy section d6a: if implanted, give date: not applicable, as there was no patient contact with the product.Section d6b: if explanted, give date: not applicable, as there was no patient contact with the product.Section e1: initial reporter telephone number: (b)(6).Section h3-other (81): the device was not returned for analysis; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the plunger got stuck and customer was unable to advance the preloaded intraocular lens (iol).Upon examination, the optic appeared to be damaged by the plunger so the decision was made to open a second device of the same model, dcb00.The same thing happened again and the account implanted a different model lens instead, zcb00.The process of preparing the lenses were as recommended, chamber filled with balanced salt solution (bss), small amount of provisc to the tip and in both lenses, device advancement after more than 30 seconds.No further information was provided.This is report 1 of 2 for the first dcb00.A separate report is being submitted for the second dcb00 involved.
Additional Manufacturer Narrative
Section d9: device available for evaluation: yes.Date returned to manufacturer: 16 june 2023.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed that the lens was stuck inside of the cartridge.The cartridge could be observed to have a damaged cartridge tip, in a way consistent with a handpiece that was damaged during shipping.Further inspection of the cartridge, revealed that there was no viscoelastic residue dispersed throughout the cartridge, suggesting that an inadequate amount of ovd may have contributed to the complaint issue.The handpiece was disassembled and the assembly was inspected, no issues that could cause or contribute to the complaint issue could be identified.The lens was removed and cleaned, revealing that the lens was damaged and had a detached haptic.Based on the device evaluation of the sample as it was received, the lens damage, lens jam and resistant felt by the customer was most likely due to the lack of healon in the cartridge.There is no product deficiency identified or determined to be associated with the manufacturing process.The product was manufactured according to the established procedures and in compliance with their intended use.Manufacturing record evaluation: based on the manufacturing records review, and historical complaint review, there is no indication of a product malfunction or product quality deficiency.No nonconformity report, documentation or labeling changes, and escalations are required.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
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 17159890
• Report Number: 3012236936-2023-01504
• Device Sequence Number: 14808053
• Product Code: HQL
• UDI-Device Identifier: 05050474636231
• UDI-Public: (01)05050474636231(17)260114
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2023

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: 01/14/2026
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2023
• Supplement Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown