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

Model Number DXR00V

Device Problems Break (1069); Crack (1135); Appropriate Term/Code Not Available (3191)

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

Event Date 08/24/2023

Event Type  malfunction  

Manufacturer Narrative

Section a2, a4 and a5: unknown/ asked but not available.Section d6a: if implanted, give date: not applicable, as there is no indication that the lens was implanted.Section d6b: if explanted, give date: not applicable, as there is no indication that the lens was implanted.Section h3: other 81: the device was not returned for evaluation.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.H6- 3191 for dissatisfaction.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 by the doctor that he experienced a malfunctioning preloaded intraocular lenses (iol).The iol had a crack in the cartridge and also a crack in the optic itself.Doctor expressed dissatisfaction with the simplicity system.No further information is available.This report belongs to first among the four intraocular lenses.Separate reports are being submitted for each intraocular lens.

Manufacturer Narrative

Additional information received stated that the dxr00vu085 lens with sn (b)(4) was implanted.Section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: 10/2/2023.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed that the complaint handpiece was received with the plunger rod fully advanced.Inspection of the cartridge revealed that it was received with the cartridge tip cracked.Further inspection of the cartridge revealed that there was not viscoelastic residue dispersed throughout the length of the cartridge, suggesting that an inadequate amount of ovd/bss may have contributed to the complaint issue.The handpiece was disassembled, and the assembly was inspected, no issues that could contribute to or cause the complaint issue could be identified.Conclusion: the complaint issue ¿cartridge crack" was not confirmed during product evaluation.The observed ¿cartridge tip cracked/damaged¿ is similar to the reported complaint issue.However, based on the complaint investigation results, the observed issues during product evaluation could not be confirmed to be related to the manufacturing or design process.The complaint issue of lens damaged could not be confirmed due to no lens being returned for evaluation.If the lens is received after initial closure, the pi and cp (if necessary) may be re-opened to complete the return investigation.The complaint issue of ¿dissatisfaction - quality/design¿ was not confirmed.Based on the complaint investigation results, the product was released within specifications.The complaint issue reported could not be confirmed and no product deficiency or product malfunction could be identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SIMPLICITY
• Type of Device: EXTENDED DEPTH OF FOCUS 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: 17784190
• MDR Text Key: 323868856
• Report Number: 3012236936-2023-02389
• Device Sequence Number: 1
• Product Code: POE
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DXR00V
• Device Catalogue Number: DXR00VU085
• 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: 10/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2023
• 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