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

Model Number	ZA9003
Medical Device Problem Codes	Failure to Fold (1255); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted; give date: n/a (not applicable).Lens was removed/replaced during the same procedure.If explanted; give date: n/a (not applicable).Lens was removed/replaced during the same procedure.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the tecnis intraocular lens (iol) was fully inserted and was removed due to folding issue and a missing haptic.The procedure was completed with a back up lens.A vitrectomy was performed during the procedure.No injury was reported.The patient outcome was reported as unknown.No further information is available.
Additional Manufacturer Narrative
Product investigation information was received, and the following fields were updated accordingly: information received that came in with product return.Patient date of birth (b)(6) 1953, 68 yrs.Old, right eye.The following fields are updated.Section a-2: date of birth: (b)(6) 1953, 68 yrs.Old.Section d-9: device available for evaluation: yes section d-9: date returned to manufacturer: 12-nov-2021 section h-3: device evaluated by manufacturer: yes device evaluation: visual inspection under magnification revealed viscoelastic residue on the optic body and haptics and that the lens had been cut into three pieces, which is consistent with a lens handled during removal.A detached haptic as well as a damaged haptic were also observed.Based on the return condition of the lens, no further product evaluation could be performed on the lens.The complaint issue detached haptic was confirmed; however, based on the fact that the lens was handled during removal, it cannot be confirmed to be related to a manufacturing issue.Therefore, no product deficiency could be identified.Manufacturing records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification.No nc/er was found as part of this manufacturing records review.Historical data analysis: a search revealed that no other complaints have been received for this production order (po) number.Conclusion: as a result of the investigation, there is no indication of a product malfunction or product quality deficiency.All pertinent information available to johnson & 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 ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12661638
• Report Number: 2020664-2021-07805
• Device Sequence Number: 4490006
• Product Code: HQL
• UDI-Device Identifier: 05050474528987
• UDI-Public: (01)05050474528987(17)230515
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• 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 Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/15/2023
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2021
• 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: 09/22/2021
• Supplement Date Received by Manufacturer: 12/15/2021
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 12/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male