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

Model Number ZCB00V

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 11/07/2022

Event Type  malfunction  

Manufacturer Narrative

Section d6b: if explanted; give date: n/a (not applicable).The lens remains implanted.Section e1: telephone number:(b)(6).Section g4: this report is being filed on an international device.Tecnis optiblue 1-piece iol.That has a similar device, tecnis 1-piece iol model zcb00 which is distributed in the united states under pma p980040.Section h6 device code 3191 is provided for lathe lines.Device evaluation: the lens was not received for evaluation.The customer provided a movie and photographs which were reviewed by a manufacturing subject matter expert (sme) who determined that "based on the intensity that can be observed on the images shared, the condition seems to be out of specifications, due to the deepness observed on the lines".Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.Conclusion: based on the investigation results, the assignable cause could be due to the acceptance of a non-conforming lens during visual inspection.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 while checking the centering of the intraocular lens (iol) in the eye after implantation, the surgeon observed shadows that looked like diffraction grooves on the peripheral part of the optic where the reflected light had illuminated.There was no reported patient injury or health damage, including postoperative visual acuity.The iol remains implanted.No additional information was provided.

Manufacturer Narrative

Upon further review of the file, it was noted that the following investigation information should be included in this report (mdr # 3012236936-2023-00746) conclusion: a search of complaints related to the production order was performed february 13, 2023.The search revealed that no other complaints have been received for this production order (lot).A search of non-conformance (nc) and corrective and preventative action (capa) was conducted on march 9th, 2023.The search revealed no nc/capa related to this complaint.There are manufacturing controls in place to ensure if machine lines exceed specifications they must be rejected.An awareness was conducted to the operators of the lens generation and quality inspection areas involved in the production order of the reported complaint to reinforce visual inspection during the process, to prevent recurrence.These types of events will continue to be monitored.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• 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: 16748077
• MDR Text Key: 313620328
• Report Number: 3012236936-2023-00746
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474546714
• UDI-Public: (01)05050474546714(17)270116
• 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: 04/18/2023

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: ZCB00V
• Device Catalogue Number: ZCB00V0185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/22/2023
• Initial Date FDA Received: 04/14/2023
• Supplement Dates Manufacturer Received: 04/17/2023
• Supplement Dates FDA Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2022
• 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