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

Model Number DCB00

Device Problems Difficult to Insert (1316); Inaccurate Delivery (2339)

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

Event Date 12/08/2021

Event Type  malfunction  

Manufacturer Narrative

If implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.If explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.The intraocular lens (iol) has 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

A surgeon reported that the lens came out angled during implantation of an intraocular lens (iol) into a patient¿s right eye and the iol did not sit right.The lens was inserted and removed during the same procedure.Another johnson and johnson lens with the same model and diopter was implanted.There was no vitrectomy, no incision enlargement and no sutures required.There was no medical intervention and no delay in procedure reported.The reported issue did not affect the patient's daily life activities and it was confirmed that the patient has fully recovered.No further information was provided.

Manufacturer Narrative

Corrected data: in review, it was noted that the following information was inadvertently not included in the initial mdr report; therefore, it has been captured in this supplemental mdr report: it was indicated that the lens was unable to be inserted due to how the lens was angled in the preloaded cartridge.There was no patient injury reported.Additional information: based on the additional information received, the account clarified that the initial report was incorrect.That the only issue with this lens was that it came out angled on insertion.The lens was only partially inserted, (tip only) and not fully.The account also clarified that by stating ¿iol did not sit right¿, they meant that the lens did not sit right in the cartridge/inserter.The following fields were updated accordingly: section d6a: if implanted, give date: not applicable, as the lens was not implanted.Section d6b: if explanted, give date: not applicable, as the lens was not implanted.Hence, not explanted.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Corrected data: in review, it was noted that the code "1316 - difficult to insert" was inadvertently entered in the section "h6 - medical device problem code" of the initial mdr report which is incorrect and should not have been used.The information has been corrected in this supplemental mdr report.Additional information: section d9: device available for evaluation? yes.Section d9: returned to manufacturer: yes.Section d9: date returned to manufacturer: jan 31, 2022.Section h3: device evaluated by manufacturer: yes.Device evaluation: the complaint lens was received loose inside a plastic bag.The complaint simplicity and patient stickers were also received.Visual inspection, of the handpiece, under magnification revealed viscoelastic residue inside of the cartridge.The external assembly was inspected, a stress mark was observed inside of the cartridge however, it is within acceptable parameters, therefore, the complaint cartridge presented with no issues.Visual inspection, of the lens, revealed viscoelastic residue on the optic body and haptics.The lens was cleaned and, the lens presented with no issues.The complaint issue could not be confirmed, and no product deficiency could be determined.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: 13173131
• MDR Text Key: 286498779
• Report Number: 3012236936-2022-00051
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474636071
• UDI-Public: (01)05050474636071(17)241003
• 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: 02/14/2022

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: DCB0000195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2021
• Initial Date FDA Received: 01/05/2022
• Supplement Dates Manufacturer Received: 12/28/2021; 02/11/2022
• Supplement Dates FDA Received: 01/19/2022; 02/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2021
• 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 Sex: Female
• Patient Weight: 64 KG
• Patient Race: White