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

Model Number DCB00V

Device Problem Contamination (1120)

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

Event Type  malfunction  

Manufacturer Narrative

Age, weight, ethnicity: information unknown/ not provided.Per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Date of event: date unknown/ not provided.Catalog number: partial catalog number indicated since lot number was not provided.Serial number: unknown, information not provided.Expiration date: unknown, as the serial number was not provided.Udi number: udi number is unknown, as the serial number was not provided.Implant date: unknown/ not provided.Explant date: n/a (not applicable).The intraocular lens remains implanted.Initial reporter name and address: telephone number:(b)(6).Device manufacture date: unknown, as the serial number of the device was not provided.The device is not returning 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 have been made to obtain the missing information.However, to date, 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 a particle/fiber was found stuck on the optic of the intraocular lens (iol) after it had been implanted.Account indicated that the particle could not be removed as it was really attached to the iol.The lens remains implanted and the surgeon does not expect any visual impact for the patient.No interventions reported or are planned.No further information was provided.

Manufacturer Narrative

Corrected information: we received the product serial number on december 21, 2022.This information was inadvertently left out of the initial report 3012236936-2022-03115, which was submitted on december 23, 2022.Additional information: section d4 model number: dcb00v.Section d4 catalog number: dcb00v.Section d4: serial number: (b)(6).Section d4: expiration date: 27-jun-2025.Section d4: udi number: (b)(4).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 united states under pma p980040.Section h4: device manufacture date: 27-jun-2022.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Additional information: section h3 - device evaluated by manufacturer? yes.Device evaluation: a photograph provided by the customer was assessed.The picture shows the anterior segment of a pseudophakic eye claimed to be implanted with a tecnis simplicity optiblue intraocular lens model dcb00v.A grayish and thin image can be seen of a wavy shape with an approximate length of 2.5 mm.It could not be determined from the picture if there is a foreign particle embedded or lose.The complaint issue of foreign material - loose 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.Therefore, there is no indication of a product deficiency or product malfunction.The reported issue is an anticipated/expected event for dcb00v (tecnis simplicity one-piece intraocular lens (iol)) and does not represent a new risk.Based on the last annual risk management review and ongoing post market surveillance activities, the probability of occurrence for the reported event remains within the rates established in the product risk management files.The root cause and potential clinical impact of the reported cannot be determined from a photo assessment.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.

• 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: 16045308
• MDR Text Key: 308349128
• Report Number: 3012236936-2022-03115
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474636712
• UDI-Public: (01)05050474636712(17)250627
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 02/27/2023

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: DCB00V
• Device Catalogue Number: DCB00V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/07/2022
• Initial Date FDA Received: 12/23/2022
• Supplement Dates Manufacturer Received: 12/21/2022; 01/31/2023
• Supplement Dates FDA Received: 01/12/2023; 02/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2022
• 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 Outcome(s): Other