MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS UNK_TECNIS TORIC IOL; INTRAOCULAR LENS

Model Number UNK-TECNIS TORIC

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 05/15/2023

Event Type  malfunction  

Event Description

It was reported that the intraocular lens (iol) haptics get stuck after implantation into the patient's eye and do not get released easily.It happens in few tecnis 1 and sensar 1 iols.Doctor could not recall and provide the exact serial number for the iols.Manual intervention had to be performed to release the stuck haptics.No patient injury was reported.No further information provided.This report is for the unknown tecnis lenses.A separate report is being submitted for the unknown sensar lenses mentioned in this case.

Manufacturer Narrative

Section d6b: explant date: not applicable, as lens remains implanted.Section e1: initial reporter telephone number: (b)(6).Section h4: device manufacture date: unknown, as the serial number of the device was not provided.Device evaluation: product testing could not be performed as the product was not returned (the lens remains implanted).The reported complaint cannot be confirmed.Manufacturing record evaluation: the manufacturing record review could not be performed because the serial number of the complaint product is unknown.Since the serial number is unknown, the complaint history review could not be performed.Conclusion: since the sample of the complaint product was not returned, and serial number is unknown, it is not possible to determine a malfunction and/or product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: UNK_TECNIS TORIC IOL
• Type of Device: INTRAOCULAR LENS
• 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: 17140723
• MDR Text Key: 318016747
• Report Number: 3012236936-2023-01498
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: Physician
• Type of Report: Initial
• Report Date: 06/15/2023

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: UNK-TECNIS TORIC
• Device Catalogue Number: UNK-TECNIS TORIC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/19/2023
• Initial Date FDA Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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