MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; LENS, MULTIFOCAL INTRAOCULAR

Model Number DFR00V

Device Problems Break (1069); Operating System Becomes Nonfunctional (2996)

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

Event Date 04/20/2023

Event Type  malfunction  

Event Description

It was reported that the cartridge-part of the preloaded intraocular lens (iol) was bend and the plunger damaged the optic of the iol.Through follow-up we learned that it was not the cartridge but instead the plunger rod, that was bent, making it hard to advance the iol forward.The lens was implanted into the eye and when it was in the anterior chamber, a defect with the iol was found.The iol was replaced with a different lens from a competitor.No further information was provided.

Manufacturer Narrative

Per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.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.Telephone number: device evaluation: product testing could not be performed since the device was not returned for evaluation.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search of complaints related to this production order (po) was performed.The search revealed that no additional complaints were received for this po.No escalation required.Conclusion: a product deficiency has not been identified; therefore, no additional corrective actions have been initiated.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Additional information: section d9 - device available for evaluation? yes.Section d9 - date returned to manufacturer: june 08, 2023.Section h3 - device evaluated by manufacturer? yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection revealed a severe crack on the posterior side of the lens along with two v-shaped cracks in line.All assembly related items inspected did not show anomalies.All inspections to assembly criteria where applicable and all passed.The complaint issue of lens damaged was identified 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.The complaint issue of plunger rod issue was not confirmed.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Corrected data : upon further review of the file it was noted that the awareness date had been inadvertently submitted as 21 april 2023 in the initial mfr report number 3012236936-2023-01063 (section g3: date received by manufacturer: april 21, 2023).Instead, we first learnt about the reported issue on 20 april 2023.This filing is to state that the initial mdr should have provided date 20 april 2023 in section g3.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Type of Device: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 16950878
• MDR Text Key: 316112969
• Report Number: 3012236936-2023-01063
• Device Sequence Number: 1
• Product Code: MFK
• UDI-Device Identifier: 05050474709942
• UDI-Public: (01)05050474709942(17)250316
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• 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: DFR00VI235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2022
• 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