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

Model Number DFR00V

Device Problems Break (1069); Crack (1135); Inaccurate Delivery (2339)

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

Event Date 06/29/2022

Event Type  malfunction  

Event Description

It was reported that the preloaded device had issue in delivering the intraocular lens (iol) into patient's right eye.The lens was not delivering straight as it should be and was coming out crooked.The cartridge tip had also cracked.It was indicated that the issue was not due to use error.The lens was partially inserted into the eye which there was patient contact, however, was removed.There was no patient injury and no other intervention was required.The procedure was completed successfully with backup lens without any issues.No other information was provided.

Manufacturer Narrative

Weight and ethnicity: 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 evaluated by mfr: 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.An attempt has been made to obtain missing information; however, to date, the information has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Additional information section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: aug 18, 2022.Section h3: device evaluated by manufacturer: yes.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 lens stuck inside of the cartridge tip and that the plunger rod was overriding the lens.The plunger rod had additionally punctured the side of the cartridge at the base of the tip, cracking both the tube and the tip of the cartridge.The handpiece was disassembled and the assembly was inspected, revealing that there were no assembly issues with the handpiece that could contribute to the observed issues.The lens was removed from the cartridge and cleaned, revealing that it had a torn optic body.The haptics could also be observed to be torn, in a way that did not sever the haptic.The lens could also be observed to have creases, consistent with a lens that was folded inside of the cartridge.Conclusion: one of the complaint issue was not confirmed.The other reported complaint issues (cracked/damaged cartridge tip and damaged lens) were 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.Any additional issues observed during the product evaluation could also not be confirmed to be related to a manufacturing or design issue.Therefore, there is no indication of a product deficiency or product malfunction.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• 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: 15071402
• MDR Text Key: 304010796
• Report Number: 3012236936-2022-01938
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474750661
• UDI-Public: (01)05050474750661(17)240913
• 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: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU195
• 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: 09/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2021
• 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