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

Model Number DCB00

Device Problem Inaccurate Delivery (2339)

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

Event Date 10/11/2022

Event Type  malfunction  

Manufacturer Narrative

If implanted, give date: unknown/not reported; it is unknown if the iol had any patient contact or if it was implanted.If explanted, give date: unknown/not reported; it is unknown if the iol had any patient contact or if it was implanted.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.An attempt has been made to obtain missing information; however, the account did not have the information.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that an intraocular lens (iol) advanced too soon.No further information is available at this time.

Manufacturer Narrative

Corrected data: further information was provided with the product return and reported there was patient contact as the event occurred during surgery in the patient's right eye.Patient's date of birth, gender, and event date were provided.The surgeon's name was also reported.Therefore, the information is captured in this supplemental report.The following sections have been updated accordingly: section a2: age/date of birth: (b)(6) 1952.Section a3: sex/gender: female.Section b3: date of event: oct 11, 2022.Section e1: title: dr.Section e1: first/last name: (b)(6).Section e2: health professional: yes.Section e3: occupation: physician.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Additional info: section d9: device available for evaluation? yes section d9: returned to manufacturer on: jan 11, 2023 section h3: device evaluated by manufacturer¿ yes device evaluation: the complaint handpiece and lens were received loose inside of the original folding carton.Visual inspection under magnification revealed that the complaint handpiece was received with the cartridge tip cracked and bent.The bend, was consistent with a handpiece that was dropped.The handpiece was disassembled and the assembly was inspected, no assembly issues that could contribute to or cause the observed or complaint issue could be identified.Visual inspection under magnification of the lens revealed that it was coated in viscoelastic residue.The lens was cleaned and, no issues were identified.The complaint issue ¿uncontrolled delivery¿ was not confirmed.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be confirmed.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: 16006228
• MDR Text Key: 308471335
• Report Number: 3012236936-2022-03143
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2023

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
• Device Operator: Health Professional
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000240
• 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: 11/28/2022
• Initial Date FDA Received: 12/19/2022
• Supplement Dates Manufacturer Received: 01/26/2023; 01/26/2023
• Supplement Dates FDA Received: 01/26/2023; 01/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2022
• 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