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

Model Number	PCB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age, weight, ethnicity:unknown.If implanted, give date: not applicable, as lens was removed/replaced during the same procedure.If explanted, give date: not applicable, as lens was removed/replaced during the same procedure.Telephone number, (b)(6).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that one of the legs of the lens broke at time of injection.Another lens was used instead.There was no patient involvement.Material is available for investigation.No other information was provided.
Additional Manufacturer Narrative
Corrected data: upon review it was noted that although there was indication the complaint device was available for evaluation and would be returned by the customer, at the time of submission of the initial mdr the complaint device had not been received for evaluation and coding was not provided to support that the device has not been returned.This follow-up report is being submitted as a correction report and to update the coding to address the type of investigation, investigation finding, and investigation conclusion that should have been provided initially.To date the device still has not been returned.The following fields are being updated accordingly: section h3 ¿ other (81) section h6: type of investigation 4114, investigation finding 3221, investigation conclusion 67 section h3-other (81): 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 and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d9.Device available for evaluation? yes returned to manufacturer on:11/10/2021 section h3.Device evaluated by manufacturer? yes device evaluation: visual inspection using magnification was performed to the returned device.The plunger and pushrod was observed in advanced position.Residues of viscoelastic material was observed on cartridge.The cartridge tip was observed slightly deformed.The lens returned damaged/broken and outside the device.One of the haptics was observed detached and stuck at the cartridge tip section.No damaged was observed to the other haptic.The condition in which the material returned is consistent with a product that was handled and prepare for surgical process based on the evaluation, there is no evidence to suggest that the complaint unit has been affected by the manufacturing process.The complaint issue reported as haptic damaged was not verified.However, haptic detached was identified on the returned device.Based on the analyzed of the returned, there is no indication of product quality deficiency.Manufacturing record review: a nonconformity was found as part of the record review, however this non conformance report (ncr) did not contribute to this complaint.The manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no other complaints were received from this production order.Lens generation report was also evaluated.No deviations were found.Conclusion: based on the manufacturing record review, analysis of the returned device and historical review there is no indication of a product malfunction or quality deficiency.No nonconformity report, escalation, documentation is required.Johnson and johnson surgical vision will continue to monitor this type of complaints.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; road 402 north, anasco ind. pk; anasco, PR 00610 ; 7142478552
• MDR Report Key: 11838613
• Report Number: 2648035-2021-07763
• Device Sequence Number: 4545374
• Product Code: HQL
• UDI-Device Identifier: 05050474558311
• UDI-Public: (01)05050474558311(17)240108
• Combination Product (Y/N): N
• Initial Reporter Country: FP
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/07/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/08/2024
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 07/01/2021; 11/16/2021
• Initial Report FDA Received Date: 05/17/2021
• Supplement Report FDA Received Date: 07/30/2021; 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown