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

Model Number DCB00

Device Problems Crack (1135); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 07/11/2022

Event Type  malfunction  

Manufacturer Narrative

Weight: unknown/ asked but not available.Implant date: if implanted, give date: not applicable, as there is no indication that the lens was implanted explant date: if explanted, give date: not applicable, as there is no indication that the lens was implanted.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection under magnification revealed that the complaint handpiece was received with the plunger rod partially advanced.The cartridge tip could be observed to be cracked and the cartridge could also be observed to be damaged.The handpiece was disassembled and the assembly was inspected, no issues that could contribute to or cause the complaint issue.The lens was cleaned and, no issues were 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 investigation request (ir) for this production order number has been received.Conclusion: the reported complaint issue of broke/ cracked cartridge was observed during product evaluation; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Therefore, there is no indication of a product deficiency or product malfunction.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the cartridge of the preloaded device broke/ cracked while inserting the intraocular lens (iol) into patient's left eye.Additionally, it was also reported that there was no seal on the box.The lens was partially inserted into the eye, however, was removed and replaced with another lens of same model and diopter.The patient had recovered.No other information was provided.

• 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: 16031134
• MDR Text Key: 308458726
• Report Number: 3012236936-2022-03034
• Device Sequence Number: 1
• Product Code: HQL
• 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: Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2021
• 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: 71 YR
• Patient Sex: Male