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

Model Number DIB00V

Device Problems Difficult to Fold, Unfold or Collapse (1254); Inaccurate Delivery (2339)

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

Event Type  malfunction  

Manufacturer Narrative

If implanted; give date: unknown/not provided.The lens remains implanted.If explanted; give date: n/a (not applicable).The lens remains implanted.Telephone number: (b)(6).This report is being filed on an international device; tecnis optiblue simplicity preloaded 1-piece iol, model dib00v that has a similar device, tecnis simplicity preloaded 1-piece iol model dib00 which is distributed in the unites states under pma p980040.The device was not returned for evaluation as it remains implanted; 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.

Event Description

It was reported that the trailing haptic of the intraocular lens (iol) became stuck between the plunger and the tip of the cartridge during implantation.The iol was puled out with tweezers in order to be implanted into the eye.There was no reported patient injury.No additional information was provided.

Manufacturer Narrative

Additional information: section d9: device available for evaluation? yes.Section d9: returned to manufacturer on: 12/16/2022.Section h3: device evaluated by manufacturer¿ yes.Device evaluation: no complaint lens was received with the returned product and therefore no evaluation on the lens could be performed.No defects or assembly issues were observed with the handpiece before and after disassembly.The manufacturing records review for the product showed the unit was released within specification.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: 16056722
• MDR Text Key: 308379691
• Report Number: 3012236936-2022-03214
• Device Sequence Number: 1
• Product Code: HQL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 01/30/2023

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: DIB00V
• Device Catalogue Number: DIB00VI235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2022
• Initial Date FDA Received: 12/27/2022
• Supplement Dates Manufacturer Received: 01/06/2023
• Supplement Dates FDA Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2022
• 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
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian