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

Model Number DIB00

Device Problem Scratched Material (3020)

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

Event Date 01/25/2024

Event Type  malfunction  

Manufacturer Narrative

Additional information: section d-6b date explanted: not applicable as the iol remains implanted, therefore not explanted.Section h3-81: the device was not returned for evaluation as it remains implanted in the patient¿s ocular dexter (right eye).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 report will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

After implantation of the dib00 model intraocular lens (iol) in the patient¿s ocular dexter (right eye), it was reported there were a couple of divots on the posterior surface of the optic that were pretty significant.There was no incision enlargement, serious patient injury, suture(s), and vitrectomy.Patient outcome post-procedure was reported as no problem post-op day # 1, pending 1 month evaluation.The suspect iol is not available for return as it remains implanted.No further information is available.

Manufacturer Narrative

Additional information: through follow-up, additional information was received stating the patient is very happy without any clinical complaints, uncorrected vision (at one month visit - 27-feb-2024) in the index eye was 20/30 and her corrected vision was 20/25 with a refraction of +0.25-1.00 at 089.The patient was made aware of the issue by the doctor on the day of surgery, but she is not bothered in any way.No further information is available.Section d-9: device available for evaluation: yes.Section d-9: device date returned to manufacturer: 12-feb-2024.Section h-3: device evaluated by manufacturer: yes.Device evaluation: the complaint simplicity was received inside the original folding carton.The patient stickers and a piece of medical gauze was also received.The complaint simplicity was visually inspected under magnification revealing that the plunger rod tip was slightly damaged.No further issues were observed with the complaint simplicity.No lens was received for evaluation.Complaint issue "cosmetic issues" was not identified during product evaluation.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.Conclusion: based on the complaint investigation results, the product was released within specifications and the reported complaint issue could not be confirmed.No product deficiency or product malfunction was identified.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: 18728339
• MDR Text Key: 336629522
• Report Number: 3012236936-2024-00418
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/15/2024

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
• Device Operator: Health Professional
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/25/2024
• Initial Date FDA Received: 02/17/2024
• Supplement Dates Manufacturer Received: 03/03/2024
• Supplement Dates FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2023
• 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
• Patient Sex: Female
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White