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

Model Number DCB00V

Device Problems Material Fragmentation (1261); Mechanical Problem (1384); Device Difficult to Setup or Prepare (1487)

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

Event Date 07/26/2022

Event Type  malfunction  

Event Description

It was reported that when turning the plunger of an intraocular lens (iol), the reporting physician got a resistance feeling and its haptic got detached because the plunger rod could not grip the lens in its cartridge.There was no patient contact as the issue was prior to use.There was no patient injury.No other information was provided.

Manufacturer Narrative

Age or date of birth, sex, weight, ethnicity: not applicable as there was no patient involvement.If implanted, give date: not applicable, as lens was not implanted.If explanted, give date: not applicable, as lens was not implanted, hence not removed.Telephone number: (b)(6) device evaluated by mfr:81 - other: the device is not returned; therefore, a failure analysis of the complaint device cannot be completed.A review of the device record and complaint trending 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 have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Corrected data: upon further review it was observed that the date (b)(6) 2021) was inadvertently entered in the section "h4" of the initial mdr report which is incorrect.The correct date that should have been entered is "(b)(6) 2021".It was also noted that the section "g4" of the initial mdr report was inadvertently populated with the pma# p980040 which is incorrect.The "g4" field should have been kept blank and the justification for that should have been entered in the section "h10" of the initial mdr report.The information has been corrected in this supplemental mdr report and the following fields were updated accordingly: section g4: this report is being filed on an international device; tecnis optiblue simplicity preloaded 1-piece iol, model dcb00v that has a similar device, tecnis simplicity preloaded 1-piece iol model dcb00 which is distributed in the unites states under pma p980040.Section h4: device manufacture date: dec 7, 2021.Additional information: section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: aug 17, 2022.Section h3: evaluated by manufacturer: yes.Device evaluation: the device was returned for evaluation.The complaint lens was observed stuck in cartridge, damaged, and torn in pieces with detached haptics inside the handpiece cartridge.No defects or assembly issues were observed with the handpiece.Viscoelastic residue was observed inside the lens module.All pertinent information available to johnson & 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: 15255069
• MDR Text Key: 304989667
• Report Number: 3012236936-2022-02201
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474636699
• UDI-Public: (01)05050474636699(17)241207
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• 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: DCB00V0210
• 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: 12/07/2021
• 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