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

Model Number	AAB00
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age or date of birth, weight, and ethnicity: unknown/ not provided.Implant date: not applicable, as lens was not implanted.Explant date: not applicable, as lens was not explanted.Initial reporter email address: unknown/not provided.Initial reporter telephone number: (b)(6).An attempt has been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that when the surgeon opened the intraocular lens (iol) box, they found the iol had no sterile packaging (pouches) inside.No patient involvement.No further info available.
Additional Manufacturer Narrative
Section d9: device available for evaluation? yes.Returned to manufacturer? yes.Date returned to manufacturer: june 21, 2021.Section h3: device evaluated by manufacturer? yes.Device evaluation: sterility assurance issues cannot be confirmed, because no pouches were received with the product return.Visual inspection under magnification revealed, viscoelastic residue on the optic body and haptics.Which is consistent with a lens that was handled during implanting.The lens was cleaned, a scratch was observed, on the optic body, but this may be attributed to handling and cannot be confirmed, to be related to manufacturing.The complaint issue could not be confirmed.And no product deficiency could be identified.Manufacturing record evaluation: based on the manufacturing records review and historical complaint review, there is no indication, of a product malfunction or product quality deficiency.No nonconformity report, documentation or labeling changes, and escalations are required.A search revealed, that no other complaints have been received for this production order.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: SENSAR 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: 11861028
• Report Number: 2648035-2021-07853
• Device Sequence Number: 3789378
• Product Code: HQL
• UDI-Device Identifier: 05050474548695
• UDI-Public: (01)05050474548695(17)241004
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2021

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: 10/04/2024
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 05/20/2021
• Supplement Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1