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

Model Number	Z9002
Medical Device Problem Codes	Break (1069); Failure to Fold (1255)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: not applicable as lens was not implanted.If explanted, give date: not applicable as lens was not implanted, then it was not explanted.All pertinent information available to johnson and johnson surgical vision has been submitted.
Event or Problem Description
It was reported that a z9002 intraocular lens (iol) had folding issues and haptic bent.The lens was not implanted in patient's eye.However, there was patient contact during handling.No adverse effect, injury or surgical intervention required.No other information was provided.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes returned to manufacturer on 3/16/2021 section h3: device evaluated by manufacturer: yes device evaluation: visual inspection under magnification revealed viscoelastic residue on the optic body and haptics, which is consistent with a lens that was handled.The lens was cleaned, and no cosmetic defects were observed.The complaint issue could not be confirmed, and no product deficiency could be identified.Manufacturing records review: the manufacturing records for the product were reviewed, shows that the units were released within specification.No nc/er was found as part of this manufacturing records review.Historical data analysis: the search revealed that one complaint was found as part of this production order and is coded for "stuck in cartridge" which is not related to the codes used in this investigation (pi-0008300).Furthermore, this complaint meets the criteria for no further investigation to be performed; therefore, no product malfunction or deficiency could be identified and no escalations are required.Conclusion: as a result of the investigation, there is no indication of a quality product deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS CL IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• MDR Report Key: 11375665
• Report Number: 2648035-2021-07294
• Device Sequence Number: 3859535
• Product Code: HQL
• UDI-Device Identifier: 05050474530690
• UDI-Public: (01)05050474530690(17)240815
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2021

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: 08/15/2024
• Device Model Number: Z9002
• Device Catalogue Number: Z900200200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 04/11/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 05/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1