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

Model Number DCB00V

Device Problems Material Fragmentation (1261); Physical Resistance/Sticking (4012)

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

Event Type  malfunction  

Event Description

It was reported that the lead haptic of the intraocular lens (iol) was stuck to the optic when implanted into the eye.The haptic detached while being manually released.The iol was then cut and removed from the eye.A replacement iol was successfully implanted into the eye.No additional information was provided.

Manufacturer Narrative

Implant date: if implanted, give date: not applicable, as lens was removed/replaced during the same procedure.Explant date: if explanted, give date: not applicable, as lens was removed/replaced during the same procedure.Initial reporter name and address: telephone number: (b)(6).This report is being filed on an international device; tecnis optiblue 1-piece iol with tecnis simplicity, model dcb00v that has a similar device, tecnis 1-piece iol with tecnis simplicity model dcb00 which is distributed in the unites states under pma p980040.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.Attempts were made to obtain the missing information; however, no response has been received.All pertinent information available to johnson and 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: 16565975
• MDR Text Key: 312201294
• Report Number: 3012236936-2023-00670
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DCB00V
• Device Catalogue Number: UNK-DCB00V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2023
• 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
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian