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

Model Number PCB00

Device Problems Break (1069); Mechanical Problem (1384)

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

Event Date 07/26/2022

Event Type  malfunction  

Manufacturer Narrative

Weight and ethnicity: unknown/ not provided.Implant date: if implanted, give date: not applicable, as lens was not implanted.Explant date: if explanted, give date: not applicable, as lens was not implanted; therefore, not explanted.Initial reporter name and address: telephone number, (b)(6).Device evaluated by mfr: the intraocular lens (iol) 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.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

Event Description

Customer reported that the plunger went straight through the tecnis itec preloaded intraocular lens (iol).The physician retracted the plunger, put more methyl and managed to get the plunger to take the lens.Physician took the iol out to see if it was intact.Physician would use a platinum cartridge to perform the implant, but the lens had a malfunction (cracked or scratched) in the optical zone.There was no patient contact and issue occurred during handling/prior to insertion.Due to what happened, there was an increase in the surgical time.It was necessary to open another lens (the same degree of lens was available at the clinic).Despite the increase in surgical time, the patient was not affected because a new lens was implanted.Patient fully recovered.Patient's daily activities were not significantly affected.Medication was prescribed for standard postoperative use.Patient did not seek medical attention.No surgical interventions were required.No further information provided.

• Brand Name: TECNIS IOL
• 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: 15325725
• MDR Text Key: 298971666
• Report Number: 3012236936-2022-02284
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474558311
• UDI-Public: (01)05050474558311(17)231023
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/23/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2020
• 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 Age: 73 YR
• Patient Sex: Female