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

Model Number DCB00

Device Problems Break (1069); Failure to Advance (2524)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/09/2021

Event Type  malfunction  

Manufacturer Narrative

Section a4 and a5: unknown; section d6a: if implanted, give date: not applicable, as there was no indication that the lens was implanted.Section d6b: if explanted, give date: not applicable, as there was no indication that the lens was implanted.Device evaluation: the device was not returned at the manufacturing site; therefore, product testing could not be performed, and the customer¿s reported complaint could not be verified.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search of complaints related to this production order (po) was performed.The search revealed that two other complaints for this production order number have been received.Although these complaint issues reported are related, the issue could not be confirmed as related to manufacturing.Based on complaint history review (chr) results, no escalations are required.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be confirmed.Attempts were made to obtain the missing information; however, no additional information has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the preloaded intraocular lens (iol) was damaged while loading.It was noted that the lens was opened and not used.No further information was provided.

Manufacturer Narrative

Additional information: section d9: device available for evaluation? yes section d9: date returned to manufacturer: apr.19, 2023.Section h3: evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed that the complaint handpiece was received with the lens stuck inside of the neck of the cartridge.The lead haptic of the lens was also observed to be unfolded.Trace amount of viscoelastic residue could be observed inside of the cartridge, suggesting that an inadequate amount of ovd may have contributed to the observed issues.The handpiece was disassembled and the assembly was inspected, no issues with the handpiece that could cause or contribute to the complaint issue could be identified.The lens was removed from the cartridge and cleaned, revealing no issues.The complaint issue was not identified during photo and product evaluation.The observed issue is similar to the reported complaint issue and the other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.However, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.Conclusion: based on the complaint investigation results, the product was released within specifications and a relationship between the device and the reported incident could not be determined.No product deficiency or product malfunction could be identified.Correction: in reviewing the initial mdr 3012236936-2023-00855, it was noticed that section b4 date of this report was inadvertently left blank but should have been apr 6, 2023; therefore, this corrected information is captured in this supplemental report.Please note that the information reported in sections d2 (common device name), h.6 (health effect -clinical code and medical device problem code) and section g.1 (manufacturer contact e-mail) is information that remains unchanged from the initial emdr report.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SIMPLICITY
• Type of Device: 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: 16696681
• MDR Text Key: 313212532
• Report Number: 3012236936-2023-00855
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474636125
• UDI-Public: (01)05050474636125(17)231123
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/23/2023
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 80 YR